DECIFER: Depression and Citalopram In First Episode Recovery

• Sponsor: NYU Langone Health (Other)
• Overall Status: Completed
• CT.gov ID: NCT01041274
• Collaborator: National Institute of Mental Health (NIMH) (NIH)
• Enrollment: 95
• Location: 1
• Arms: 2
• Actual Duration (Months): 98.8
• Patients Per Site Per Month: 1

Study Details

Study Description

Brief Summary

This study seeks to examine the effectiveness of citalopram added to treatment with any oral or injectable second-generation antipsychotic plus standardized psychoeducation in first episode schizophrenia patients. Because depressive symptoms are common in first episode patients, we will test the hypothesis that adding the SSRI citalopram to a pre-established medication regimen will improve quality of life and decrease relapse and suicidality over the course of a 12-month trial.

Condition or Disease	Intervention/Treatment	Phase
Schizophrenia; Schizophreniform Disorder	Drug: Citalopram; Drug: Placebo; Behavioral: Psychoeducation; Behavioral: Cognitive Behavioral Therapy (CBT); Radiation: Functional Magnetic Resonance Imaging (fMRI)	Phase 4

Detailed Description

We propose to conduct a 12-month, placebo-controlled, double-blind, parallel-group trial of citalopram added to treatment with any oral or injectable second-generation antipsychotic plus standardized psychoeducation. Subjects will be 100 patients ages 16-40 with first episode schizophrenia or schizophreniform disorder with onset before age 35 who have received at least 4 weeks and fewer than 16 cumulative weeks of antipsychotic medication, have not been treated with an SSRI within four weeks and do not meet criteria for major depression or significant suicidal ideation. This study will be conducted by the Schizophrenia Program of the NYU Langone Medical Center and at the Psychiatry Outpatient Clinic of Bellevue Hospital located in New York, NY

Upon signing consent, patients will undergo screening procedures to assess eligibility. A diagnosis of schizophrenia or schizophreniform disorder will be determined by the Structured Clinical Interview for DSM IV (SCID) completed by a research clinician using all available clinical data and will be confirmed by consensus diagnosis. A comprehensive medical history and physical exam, including measurement of vital signs, will be performed. A psychiatric history, including diagnosis, treatment history, current medications, and substance use will also be performed. At screening only, a fasting blood sample will be obtained to perform routine laboratory tests including electrolytes, BUN, creatinine, liver function tests, fasting glucose, calcium, phosphate, magnesium, albumin and CBC with differential. Urinalysis will be performed to identify unstable medical illness. A urine toxicology screen will be performed and a urine pregnancy test will be done for women of child bearing potential. A research assistant will complete the demographics and administer the Calgary Depression Scale for Schizophrenia (CDSS), Scale for the Assessment of Negative Symptoms (SANS) and InterSePT Scale for Suicidal Thinking (ISST) to determine whether inclusion criteria are met.

Subjects who meet study eligibility criteria will complete the baseline assessment which will include the following assessments: Brief Psychiatric Rating Scale (BPRS), SANS, CDSS, ISST, Clinical Global Impression for Severity of Suicidality (CGI-SS), Clinical Global Impression (CGI), Heinrich Quality of Life Scale (QLS), WHO Quality of Life Scale (WHO-QOL), Scale for the Assessment of Positive Symptoms-Delusions (SAPS-D),Birchwood Insight Scale (IS), Brief Time Use Survey (BTUS), MIRECC Global Assessment of Functioning (MIRECC GAF), Beck Depression Inventory-II (BDI-II), State-Trait Anxiety Inventory (STAI),MacArthur Perceived Coercion Scale (PCS), Basis-24, Subject Well-being under Neuroleptic Scale (SWN-S),Subjective Scale to Investigate Cognition in Schizophrenia (SSTICS), Brief Adherence Rating Scale (BARS), Medication Adherence Rating Scale (MARS), Social Behavior Scale (SBS), WHO Alcohol Smoking and Substance Involvement Screening Test (WHO ASSIST), and a Drug Use Survey. In addition, side effects will be rated using the Systematic Assessment for Treatment Emergent Events (SAFTEE), Abnormal Involuntary Movement Scale (AIMS), Barnes Akathisia Scale (BAS) and the Simpson Angus Scale for Extrapyramidal Symptoms (SAS). Assessment of cognitive functioning will be measured by the MATRICS battery.

Subjects will undergo 4 high-resolution MP-RAGE scans: once each at Baseline, 2 months, 6 months and 12 months. Scheduled Participants will be randomized 1:1 to citalopram or placebo. We will follow a standard approach to flexible dosing with citalopram as recommended by the manufacturer, initiating treatment with a dose of 20 mg (two capsules) daily. Clinicians may increase or decrease the dose by one capsule every two weeks to a maximum of 4 capsules and a minimum of one capsule daily.

Beginning at Week 1, participants will receive 16 sessions of weekly, individual psychoeducation and relapse prevention planning followed by 8 monthly sessions. Participants who score 3 (moderate suicidality) on the CGI-SS or > 7 on the CDSS will be treated with a standard 12 session CBT approach to depression that includes elements targeting suicidality when appropriate. Clinical judgment will be used to determine whether to offer the CBT for depression sessions once or twice weekly.

The CDSS, ISST, and CGI-SS will be administered at baseline and then weekly up to week 8, then monthly. The SANS, BPRS, and BARS will be administered at baseline, then monthly for the duration of the study. The Heinrich's QOL and WHO QOL will be administered at baseline, and then monthly until study completion, excepting week 28, week 36, week 44, and week 48. The SAPS-D,IS, BTUS, MIRECC GAF, CGI, STAI, PCS, Basis-24, SWN-S, SSTICS, MARS, and SBS will be administered at baseline, week 24, and week 52. The BDI-II will be administered at screening, baseline, weeks 1-16, then monthly. The WHO-ASSIST will be administered at baseline, week 12, week 24, and week 52. The drug use survey will be administered at baseline, week 4, week 8, week 12, week 16, week 20, week 24, and week 52.

A fasting blood sample will be drawn at Baseline, weeks 4 and 8 and every 8 weeks thereafter for BDNF assay. Blood samples collected at Baseline, week 24, and week 52 will be assayed for prolactin and inflammation markers. Blood samples collected at baseline, week 8, week 24, and week 52 will be assayed for C-Reactive Protein. Additionally, a blood sample for DNA will be collected at week 4. Saliva will be collected with tongue swabs at Baseline, Week 4, Week 8, Week 16, Week 24, Week 36, and Week 52 for cortisol analyses.

Participants who choose to discontinue study drug will be asked if they are willing to continue their scheduled assessments. These subjects will continue to be followed for the entire course of the study but will not receive any study medication. Final study visit will be conducted 1 year post randomization.

The primary outcome measure is change in depression symptoms as measured by the Calgary Depression Scale total score. Secondary outcome measures include a measure of changes in negative symptoms (SANS), relapse rates (BPRS), suicidal ideation (ISST), and quality of life (QOL), measured at various time points during the 12-month trial.

Study Design

• Study Type: Interventional
• Actual Enrollment: 95 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Citalopram in First Episode Schizophrenia
• Actual Study Start Date: Jan 1, 2010
• Actual Primary Completion Date: Dec 1, 2014
• Actual Study Completion Date: Mar 26, 2018

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Citalopram Participants will receive a daily dose of citalopram, with flexible dosing as determined by clinician, for 12 months.	Drug: Citalopram; 40 mg by mouth daily for 12 months. Dosing will start at 20mg daily and may be increased after a minimum of one week to the target dose of 40 mg daily. Dose decreases will be made in the presence of side effects. Allowed dose range will be 10 mg daily to 40 mg daily.; Other Names: Celexa Cipramil
Placebo Comparator: Placebo Participants will receive a daily dose of placebo for 12 months.	Drug: Placebo; Placebo by mouth daily for 12 months.; Other Names: Sugar pill ; Behavioral: Psychoeducation; 16 sessions of weekly, individual psychoeducation and relapse prevention planning followed by 8 monthly sessions; Other Names: Therapy ; Behavioral: Cognitive Behavioral Therapy (CBT); Participants who exhibit symptoms of moderate suicidality at any point during the trial will be treated with 12 sessions of CBT, either once or twice weekly based on clinical judgment. Participants who continue to exceed suicidality criteria after 4 weeks of CBT will be dropped from double-blind treatment and may be prescribed openly an SSRI; Other Names: Therapy ; Radiation: Functional Magnetic Resonance Imaging (fMRI); 3 1-hour sessions of fMRI brain scanning, assessed at baseline, and weeks 24 and 52; Other Names: Neuroimaging

Outcome Measures

Primary Outcome Measures

1. Calgary Depression Scale for Schizophrenia (CDSS) [Screening, Baseline, Weeks 1-8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52]

   The Calgary Depression Scale for Schizophrenia (CDSS) is a rater-administered assessment that measures depression in schizophrenia. The scale consists of 9 questions each rated 0 to 3. 0 corresponds with "absent" and 3 corresponds with "severe". The total score for all items is provided for each time point. The minimum score is 0 and the maximum score is 27. A higher score indicates increased depressive symptoms.

Secondary Outcome Measures

1. Scale for the Assessment of Negative Symptoms (SANS) [Screening, Baseline, Weeks 4, 8, 12, 16, 20, 24, 28,32, 36, 40, 44, 48, 52]

   The Scale for the Assessment of Negative Symptoms (SANS) is a 25-item rater-administered scale to assess negative symptoms in schizophrenia. Each item is rated from 0 to 5 where 0 is "none" and 5 is "severe". The SANS consists of five subscales: affective flattening/blunting, alogia, avolition/apathy, ahnedonia/asociality, and attention. Each subscale contains a "global rating" item which assesses the overall severity of symptoms within the subscale. The total score consists of a sum of all items except the global ratings and items 10, 23, 24, and 25. The total score is reported for each time point. The minimum total score is 0 and the maximum total score is 85. A higher score indicates increased severity of negative symptoms.

2. Brief Psychiatric Rating Scale (BPRS) [Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52]

   The Brief Psychiatric Rating Scale (BPRS) is a 24-item rater-administered scale assessing overall psychiatric and psychotic symptoms. Items 1-14 are assessed through self-report and items 15-24 are assessed on the basis of observed behavior. Each item is rated from 1 to 7 where 1 is "not present" and 7 is "extremely severe". A score of 0 indicates "not assessed". The total score is a sum of all items and is reported for each time point. The minimum score is 24 and the maximum score is 168, and higher values indicate increased symptom severity.

3. InterSePT Scale for Suicidal Thinking (ISST) [Screening, Baseline, Weeks 1-8]

   IntraSePT Scale for Suicidal Thinking (ISST) consists of 12 questions rated from 0 to 2 with increasing intensity (i.e. none, weak, moderate to stron). It quantifies the current conscious and overtly expressed suicidal thinking in schizophrenic patients by canvassing various suicidal thoughts and wishes during a 20- to 30-min semi-structured interview. The total score is computed by adding the 12 individual item scores and ranges from 0 to 24. A score of zero indicates low suicidal ideation and a score of 24 indicates high suicidal ideation.

4. Heinrich Quality of Life Scale (QOL) [Baseline, Week 4, 8, 12, 16, 20, 24, 32, 40, 52]

   The Quality of Life Scale (QOL) is a 21-item scale based on a semi-structured interview to assess functional deficits in schizophrenia. Each item is rated on a 7-point scale where 0 indicates a normal level of functioning, or no deficit, and 6 corresponds to more severe deficit. The total score is a sum of all items. The minimum total score is 0 and the maximum total score is 126, higher scores indicate increased impairment in functioning.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 16 Years to 40 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Male or female

• Ages 16-40 years

• Schizophrenia, any subtype or Schizophreniform disorder

• Treated with any of the following second generation antipsychotics for at least 4 weeks and fewer than 16 weeks: risperidone, olanzapine, quetiapine, aripiprazole, ziprasidone, or paliperidone)

• Willing to participate in psychoeducation

• Sufficient proficiency in English to complete assessments

Exclusion Criteria:

• Major depression by DSM-IV criteria

• Clinical Global Assessment of Severity of Suicidality of 3 (moderate) or greater.

• Calgary Depression Scale for Schizophrenia (CDRS) score of 7 or greater

• Serious suicide attempt within three years or ANY suicide attempt for subjects age 16-25.

• Current treatment with an MAOI or pimozide

• Active alcohol or other substance abuse or dependence within three months

• Unstable medical illness

• History of SSRI intolerance

• Pregnant or nursing

• QTc ≥ 500 msec

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	New York University Langone Medical Center/ Bellevue Hospital	New York	New York	United States	10016

Sponsors and Collaborators

• NYU Langone Health
• National Institute of Mental Health (NIMH)

Investigators

• Principal Investigator: Donald C Goff, MD, NYU Langone Health

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: NYU Langone Health
• ClinicalTrials.gov Identifier: NCT01041274
• Other Study ID Numbers: 12-01965; 1R01MH084900-01A1
• First Posted: Dec 31, 2009
• Last Update Posted: Dec 17, 2019
• Last Verified: Dec 1, 2019

• Keywords provided by NYU Langone Health: Schizophrenia; Citalopram; First episode; fMRI; Cognitive behavioral therapy; Psychoeducation
• Additional relevant MeSH terms: Schizophrenia; Psychotic Disorders; Citalopram

Study Results

Participant Flow

Arm/Group Title	Citalopram	Placebo
Arm/Group Description	Participants will receive a daily dose of citalopram, with flexible dosing as determined by clinician, for 12 months. Citalopram: 40 mg by mouth daily for 12 months. Dosing will start at 20mg daily and may be increased after a minimum of one week to the target dose of 40 mg daily. Dose decreases will be made in the presence of side effects. Allowed dose range will be 10 mg daily to 40 mg daily.	Participants will receive a daily dose of placebo for 12 months. Placebo: Placebo by mouth daily for 12 months. Psychoeducation: 16 sessions of weekly, individual psychoeducation and relapse prevention planning followed by 8 monthly sessions Cognitive Behavioral Therapy (CBT): Participants who exhibit symptoms of moderate suicidality at any point during the trial will be treated with 12 sessions of CBT, either once or twice weekly based on clinical judgment. Participants who continue to exceed suicidality criteria after 4 weeks of CBT will be dropped from double-blind treatment and may be prescribed openly an SSRI Functional Magnetic Resonance Imaging (fMRI): 3 1-hour sessions of fMRI brain scanning, assessed at baseline, and weeks 24 and 52
Period Title: Overall Study
STARTED	49	46
COMPLETED	26	25
NOT COMPLETED	23	21

Baseline Characteristics

Arm/Group Title	Citalopram	Placebo	Total
Arm/Group Description	Participants will receive a daily dose of citalopram, with flexible dosing as determined by clinician, for 12 months. Citalopram: 40 mg by mouth daily for 12 months. Dosing will start at 20mg daily and may be increased after a minimum of one week to the target dose of 40 mg daily. Dose decreases will be made in the presence of side effects. Allowed dose range will be 10 mg daily to 40 mg daily.	Participants will receive a daily dose of placebo for 12 months. Placebo: Placebo by mouth daily for 12 months. Psychoeducation: 16 sessions of weekly, individual psychoeducation and relapse prevention planning followed by 8 monthly sessions Cognitive Behavioral Therapy (CBT): Participants who exhibit symptoms of moderate suicidality at any point during the trial will be treated with 12 sessions of CBT, either once or twice weekly based on clinical judgment. Participants who continue to exceed suicidality criteria after 4 weeks of CBT will be dropped from double-blind treatment and may be prescribed openly an SSRI Functional Magnetic Resonance Imaging (fMRI): 3 1-hour sessions of fMRI brain scanning, assessed at baseline, and weeks 24 and 52	Total of all reporting groups
Overall Participants	49	46	95
Age (Years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Years]	23.2 (5.09)	23.69 (4.63)	23.44 (4.85)
Sex: Female, Male (Count of Participants)
Female	17 34.7%	18 39.1%	35 36.8%
Male	32 65.3%	28 60.9%	60 63.2%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%
Asian	27 55.1%	23 50%	50 52.6%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%
Black or African American	4 8.2%	8 17.4%	12 12.6%
White	16 32.7%	13 28.3%	29 30.5%
More than one race	0 0%	0 0%	0 0%
Unknown or Not Reported	2 4.1%	2 4.3%	4 4.2%

Outcome Measures

1. Primary Outcome

Title	Calgary Depression Scale for Schizophrenia (CDSS)
Description	The Calgary Depression Scale for Schizophrenia (CDSS) is a rater-administered assessment that measures depression in schizophrenia. The scale consists of 9 questions each rated 0 to 3. 0 corresponds with "absent" and 3 corresponds with "severe". The total score for all items is provided for each time point. The minimum score is 0 and the maximum score is 27. A higher score indicates increased depressive symptoms.
Time Frame	Screening, Baseline, Weeks 1-8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52

Outcome Measure Data

Analysis Population Description

Not all participants completed the CDRS assessment at each time point. Results are reported for all participants who completed the CDRS assessment.

Arm/Group Title	Citalopram	Placebo
Arm/Group Description	Participants will receive a daily dose of citalopram, with flexible dosing as determined by clinician, for 12 months. Citalopram: 40 mg by mouth daily for 12 months. Dosing will start at 20mg daily and may be increased after a minimum of one week to the target dose of 40 mg daily. Dose decreases will be made in the presence of side effects. Allowed dose range will be 10 mg daily to 40 mg daily.	Participants will receive a daily dose of placebo for 12 months. Placebo: Placebo by mouth daily for 12 months. Psychoeducation: 16 sessions of weekly, individual psychoeducation and relapse prevention planning followed by 8 monthly sessions Cognitive Behavioral Therapy (CBT): Participants who exhibit symptoms of moderate suicidality at any point during the trial will be treated with 12 sessions of CBT, either once or twice weekly based on clinical judgment. Participants who continue to exceed suicidality criteria after 4 weeks of CBT will be dropped from double-blind treatment and may be prescribed openly an SSRI Functional Magnetic Resonance Imaging (fMRI): 3 1-hour sessions of fMRI brain scanning, assessed at baseline, and weeks 24 and 52
Measure Participants	49	46
Screening	1.93 (1.74)	2.26 (1.74)
Baseline	1.83 (1.79)	2.58 (2.99)
Week 1	2.13 (2.47)	1.94 (3.03)
Week 2	2.00 (2.34)	1.84 (2.53)
Week 3	2.4 (2.80)	1.87 (2.53)
Week 4	1.34 (1.95)	1.79 (1.79)
Week 5	1.54 (2.11)	1.67 (1.78)
Week 6	1.29 (1.54)	1.07 (1.34)
Week 7	1.20 (1.32)	2.15 (2.76)
Week 8	1.08 (2.27)	1.49 (1.82)
Week 12	1.41 (2.48)	1.32 (2.03)
Week 16	.97 (1.44)	.72 (1.22)
Week 20	1.11 (2.06)	1.23 (1.61)
Week 24	1.32 (1.89)	1.20 (1.61)
Week 28	.67 (1.27)	1.14 (1.30)
Week 32	.71 (1.12)	.81 (1.33)
Week 36	.42 (.86)	1.06 (1.29)
Week 40	.96 (1.69)	1.21 (1.93)
Week 44	.63 (1.53)	1.55 (1.76)
Week 48	.5 (.89)	1.3 (1.72)
Week 52	.4 (1.08)	1.15 (1.68)

2. Secondary Outcome

Title	Scale for the Assessment of Negative Symptoms (SANS)
Description	The Scale for the Assessment of Negative Symptoms (SANS) is a 25-item rater-administered scale to assess negative symptoms in schizophrenia. Each item is rated from 0 to 5 where 0 is "none" and 5 is "severe". The SANS consists of five subscales: affective flattening/blunting, alogia, avolition/apathy, ahnedonia/asociality, and attention. Each subscale contains a "global rating" item which assesses the overall severity of symptoms within the subscale. The total score consists of a sum of all items except the global ratings and items 10, 23, 24, and 25. The total score is reported for each time point. The minimum total score is 0 and the maximum total score is 85. A higher score indicates increased severity of negative symptoms.
Time Frame	Screening, Baseline, Weeks 4, 8, 12, 16, 20, 24, 28,32, 36, 40, 44, 48, 52

Outcome Measure Data

Analysis Population Description

Not all participants completed the SANS assessment at each time point. Results are reported for all participants who completed the SANS assessment.

Arm/Group Title	Citalopram	Placebo
Arm/Group Description	Participants will receive a daily dose of citalopram, with flexible dosing as determined by clinician, for 12 months. Citalopram: 40 mg by mouth daily for 12 months. Dosing will start at 20mg daily and may be increased after a minimum of one week to the target dose of 40 mg daily. Dose decreases will be made in the presence of side effects. Allowed dose range will be 10 mg daily to 40 mg daily.	Participants will receive a daily dose of placebo for 12 months. Placebo: Placebo by mouth daily for 12 months. Psychoeducation: 16 sessions of weekly, individual psychoeducation and relapse prevention planning followed by 8 monthly sessions Cognitive Behavioral Therapy (CBT): Participants who exhibit symptoms of moderate suicidality at any point during the trial will be treated with 12 sessions of CBT, either once or twice weekly based on clinical judgment. Participants who continue to exceed suicidality criteria after 4 weeks of CBT will be dropped from double-blind treatment and may be prescribed openly an SSRI Functional Magnetic Resonance Imaging (fMRI): 3 1-hour sessions of fMRI brain scanning, assessed at baseline, and weeks 24 and 52
Measure Participants	49	46
Screening	19.89 (14.39)	16.77 (11.9)
Baseline	21.37 (14.25)	18.91 (12.08)
Week 4	16.98 (14.17)	14.58 (10.23)
Week 8	13.83 (12.04)	13.11 (10.58)
Week 12	12.38 (12.21)	14.06 (11.73)
Week 16	11.08 (11.34)	11.48 (10.14)
Week 20	12.26 (13.10)	12.29 (11.78)
Week 24	12.41 (12.06)	13.06 (11.23)
Week 28	9.9 (11.04)	12.59 (11.71)
Week 32	8.0 (9.15)	10.92 (10.77)
Week 36	8.38 (9.76)	11.68 (10.62)
Week 40	9.35 (11.93)	10.64 (12.67)
Week 44	7.54 (8.92)	12.64 (12.98)
Week 48	7.54 (9.10)	13.0 (13.88)
Week 52	13.83 (12.04)	11.64 (13.92)

3. Secondary Outcome

Title	Brief Psychiatric Rating Scale (BPRS)
Description	The Brief Psychiatric Rating Scale (BPRS) is a 24-item rater-administered scale assessing overall psychiatric and psychotic symptoms. Items 1-14 are assessed through self-report and items 15-24 are assessed on the basis of observed behavior. Each item is rated from 1 to 7 where 1 is "not present" and 7 is "extremely severe". A score of 0 indicates "not assessed". The total score is a sum of all items and is reported for each time point. The minimum score is 24 and the maximum score is 168, and higher values indicate increased symptom severity.
Time Frame	Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52

Outcome Measure Data

Analysis Population Description

Not all participants completed the BPRS assessment at each time point. Results are reported for all participants who completed the BPRS assessment.

Arm/Group Title	Citalopram	Placebo
Arm/Group Description	Participants will receive a daily dose of citalopram, with flexible dosing as determined by clinician, for 12 months. Citalopram: 40 mg by mouth daily for 12 months. Dosing will start at 20mg daily and may be increased after a minimum of one week to the target dose of 40 mg daily. Dose decreases will be made in the presence of side effects. Allowed dose range will be 10 mg daily to 40 mg daily.	Participants will receive a daily dose of placebo for 12 months. Placebo: Placebo by mouth daily for 12 months. Psychoeducation: 16 sessions of weekly, individual psychoeducation and relapse prevention planning followed by 8 monthly sessions Cognitive Behavioral Therapy (CBT): Participants who exhibit symptoms of moderate suicidality at any point during the trial will be treated with 12 sessions of CBT, either once or twice weekly based on clinical judgment. Participants who continue to exceed suicidality criteria after 4 weeks of CBT will be dropped from double-blind treatment and may be prescribed openly an SSRI Functional Magnetic Resonance Imaging (fMRI): 3 1-hour sessions of fMRI brain scanning, assessed at baseline, and weeks 24 and 52
Measure Participants	49	46
Baseline	39 (11.5)	38.0 (9.3)
Week 4	33.11 (7.3)	33.1 (6.7)
Week 8	33.3 (9.2)	33.2 (8.0)
Week 12	33.8 (10.0)	33.2 (7.2)
Week 16	27.9 (5.9)	29.1 (4.9)
Week 20	33.1 (9.9)	31.2 (7.5)
Week 24	32.6 (9.8)	32.7 (7.6)
Week 28	29.6 (5.5)	31.6 (7.3)
Week 32	29.4 (5.5)	29.9 (5.6)
Week 36	28.6 (5.3)	32.2 (9.7)
Week 40	31.1 (7.7)	31.4 (8.3)
Week 44	30.1 (7.9)	33.5 (10.1)
Week 48	30.0 (6.7)	32.6 (9.0)
Week 52	29.1 (6.9)	32.7 (11.2)

4. Secondary Outcome

Title	InterSePT Scale for Suicidal Thinking (ISST)
Description	IntraSePT Scale for Suicidal Thinking (ISST) consists of 12 questions rated from 0 to 2 with increasing intensity (i.e. none, weak, moderate to stron). It quantifies the current conscious and overtly expressed suicidal thinking in schizophrenic patients by canvassing various suicidal thoughts and wishes during a 20- to 30-min semi-structured interview. The total score is computed by adding the 12 individual item scores and ranges from 0 to 24. A score of zero indicates low suicidal ideation and a score of 24 indicates high suicidal ideation.
Time Frame	Screening, Baseline, Weeks 1-8

Outcome Measure Data

Analysis Population Description

Given the low scores on this assessment, data collection was discontinued.

Arm/Group Title	Citalopram	Placebo
Arm/Group Description	Participants will receive a daily dose of citalopram, with flexible dosing as determined by clinician, for 12 months. Citalopram: 40 mg by mouth daily for 12 months. Dosing will start at 20mg daily and may be increased after a minimum of one week to the target dose of 40 mg daily. Dose decreases will be made in the presence of side effects. Allowed dose range will be 10 mg daily to 40 mg daily.	Participants will receive a daily dose of placebo for 12 months. Placebo: Placebo by mouth daily for 12 months. Psychoeducation: 16 sessions of weekly, individual psychoeducation and relapse prevention planning followed by 8 monthly sessions Cognitive Behavioral Therapy (CBT): Participants who exhibit symptoms of moderate suicidality at any point during the trial will be treated with 12 sessions of CBT, either once or twice weekly based on clinical judgment. Participants who continue to exceed suicidality criteria after 4 weeks of CBT will be dropped from double-blind treatment and may be prescribed openly an SSRI Functional Magnetic Resonance Imaging (fMRI): 3 1-hour sessions of fMRI brain scanning, assessed at baseline, and weeks 24 and 52
Measure Participants	49	46
Screening	0.184 (0.808)	0.643 (2.57)
Baseline	0.605 (1.76)	0.462 (1.57)
Week 1	0.667 (2.14)	0.263 (0.806)
Week 2	0.293 (1.585)	0.0 (0.0)
Week 3	0.136 (0.640)	1.00 (3.29)
Week 4	0.0 (0.0)	0.0 (0.0)
Week 5	0.357 (1.34)	0.0 (0.0)
Week 6	0.125 (0.50)	0.0 (0.0)
Week 7	0.0 (0.0)	0.0 (0.0)
Week 8	0.0 (0.0)	0.20 (0.816)

5. Secondary Outcome

Title	Heinrich Quality of Life Scale (QOL)
Description	The Quality of Life Scale (QOL) is a 21-item scale based on a semi-structured interview to assess functional deficits in schizophrenia. Each item is rated on a 7-point scale where 0 indicates a normal level of functioning, or no deficit, and 6 corresponds to more severe deficit. The total score is a sum of all items. The minimum total score is 0 and the maximum total score is 126, higher scores indicate increased impairment in functioning.
Time Frame	Baseline, Week 4, 8, 12, 16, 20, 24, 32, 40, 52

Outcome Measure Data

Analysis Population Description

Not all participants completed the QOL assessment at each time point. Results are reported for all participants who completed the QOL assessment.

Arm/Group Title	Citalopram	Placebo
Arm/Group Description	Participants will receive a daily dose of citalopram, with flexible dosing as determined by clinician, for 12 months. Citalopram: 40 mg by mouth daily for 12 months. Dosing will start at 20mg daily and may be increased after a minimum of one week to the target dose of 40 mg daily. Dose decreases will be made in the presence of side effects. Allowed dose range will be 10 mg daily to 40 mg daily.	Participants will receive a daily dose of placebo for 12 months. Placebo: Placebo by mouth daily for 12 months. Psychoeducation: 16 sessions of weekly, individual psychoeducation and relapse prevention planning followed by 8 monthly sessions Cognitive Behavioral Therapy (CBT): Participants who exhibit symptoms of moderate suicidality at any point during the trial will be treated with 12 sessions of CBT, either once or twice weekly based on clinical judgment. Participants who continue to exceed suicidality criteria after 4 weeks of CBT will be dropped from double-blind treatment and may be prescribed openly an SSRI Functional Magnetic Resonance Imaging (fMRI): 3 1-hour sessions of fMRI brain scanning, assessed at baseline, and weeks 24 and 52
Measure Participants	49	46
Baseline	71.5 (25.9)	75.9 (23.2)
Week 4	81.0 (24.3)	83.6 (21.8)
Week 8	86.2 (25.2)	87.1 (21.1)
Week 12	86.4 (27.9)	90.4 (22.7)
Week 16	89.6 (27.8)	92.1 (20.0)
Week 20	86.4 (29.6)	91.8 (23.4)
Week 24	87.4 (28.8)	92.9 (20.3)
Week 32	98.7 (26.0)	98.0 (21.4)
Week 40	100.2 (25.3)	91.1 (29.6)
Week 52	86.2 (25.2)	95.6 (28.6)

Adverse Events

Adverse Event Reporting Description	Non-serious adverse events were reported through the Systematic Assessment of Treatment Emergent Effects (SAFTEE) questionnaire unless otherwise specified.
Arm/Group Title	Citalopram		Placebo
Arm/Group Description	Participants will receive a daily dose of citalopram, with flexible dosing as determined by clinician, for 12 months. Citalopram: 40 mg by mouth daily for 12 months. Dosing will start at 20mg daily and may be increased after a minimum of one week to the target dose of 40 mg daily. Dose decreases will be made in the presence of side effects. Allowed dose range will be 10 mg daily to 40 mg daily.		Participants will receive a daily dose of placebo for 12 months. Placebo: Placebo by mouth daily for 12 months. Psychoeducation: 16 sessions of weekly, individual psychoeducation and relapse prevention planning followed by 8 monthly sessions Cognitive Behavioral Therapy (CBT): Participants who exhibit symptoms of moderate suicidality at any point during the trial will be treated with 12 sessions of CBT, either once or twice weekly based on clinical judgment. Participants who continue to exceed suicidality criteria after 4 weeks of CBT will be dropped from double-blind treatment and may be prescribed openly an SSRI Functional Magnetic Resonance Imaging (fMRI): 3 1-hour sessions of fMRI brain scanning, assessed at baseline, and weeks 24 and 52
All Cause Mortality
	Citalopram		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Citalopram		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	5/49 (10.2%)		4/46 (8.7%)
Infections and infestations
Medical Hospitalization	1/49 (2%)	1	0/46 (0%)	0
Psychiatric disorders
Psychiatric Hospitalization	3/49 (6.1%)	4	4/46 (8.7%)	4
Incarceration	1/49 (2%)	1	1/46 (2.2%)	1
Drug-related hospitalization	1/49 (2%)	1	0/46 (0%)	0
Other (Not Including Serious) Adverse Events
	Citalopram		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	22/49 (44.9%)		18/46 (39.1%)
Blood and lymphatic system disorders
Anemia	0/49 (0%)	0	1/46 (2.2%)	1
Eye disorders
Blurred vision	1/49 (2%)	1	0/46 (0%)	0
Gastrointestinal disorders
Nausea and vomiting	0/49 (0%)	0	2/46 (4.3%)	2
General disorders
Dry mouth	0/49 (0%)	0	2/46 (4.3%)	2
Hit by a motorcycle	1/49 (2%)	1	0/46 (0%)	0
Hurt when riding a bike	1/49 (2%)	1	0/46 (0%)	0
Teeth grating	1/49 (2%)	1	0/46 (0%)	0
Infections and infestations
Pneumonia	1/49 (2%)	1	0/46 (0%)	0
Metabolism and nutrition disorders
Appetite decrease	1/49 (2%)	1	2/46 (4.3%)	2
Appetite increase	2/49 (4.1%)	2	2/46 (4.3%)	2
Taste alteration	0/49 (0%)	0	1/46 (2.2%)	4
Weight increase	9/49 (18.4%)	9	6/46 (13%)	7
Musculoskeletal and connective tissue disorders
Muscle cramp	0/49 (0%)	0	1/46 (2.2%)	1
Drooling	1/49 (2%)	1	1/46 (2.2%)	1
Muscle twitch	1/49 (2%)	1	0/46 (0%)	0
Nervous system disorders
Akathisia	1/49 (2%)	1	1/46 (2.2%)	1
Difficulty thinking	0/49 (0%)	0	2/46 (4.3%)	2
Dizziness upon standing	1/49 (2%)	1	1/46 (2.2%)	4
Drowsiness	0/49 (0%)	0	1/46 (2.2%)	1
Faintness	0/49 (0%)	0	1/46 (2.2%)	1
False sensation	0/49 (0%)	0	2/46 (4.3%)	2
Fatigue	1/49 (2%)	3	2/46 (4.3%)	2
Memory impaired	2/49 (4.1%)	2	1/46 (2.2%)	4
Mental activity decreased	1/49 (2%)	1	1/46 (2.2%)	1
Numbness	0/49 (0%)	0	1/46 (2.2%)	1
Restlessness	2/49 (4.1%)	2	1/46 (2.2%)	1
Sleeplessness	1/49 (2%)	1	1/46 (2.2%)	1
Sleep disturbed	1/49 (2%)	1	0/46 (0%)	0
Psychiatric disorders
Apathy	1/49 (2%)	1	2/46 (4.3%)	2
Concentration impaired	2/49 (4.1%)	2	2/46 (4.3%)	2
Emotional dejection	0/49 (0%)	0	1/46 (2.2%)	1
Drug abuse	1/49 (2%)	2	0/46 (0%)	0
Irritability	0/49 (0%)	0	1/46 (2.2%)	1
Nightmares	1/49 (2%)	1	0/46 (0%)	0
Sensory hallucinations	1/49 (2%)	1	0/46 (0%)	0
Reproductive system and breast disorders
Anorgasmia	1/49 (2%)	1	1/46 (2.2%)	1
Loss of libido	3/49 (6.1%)	6	1/46 (2.2%)	1
Amenorrhea	2/49 (4.1%)	8	1/46 (2.2%)	2
Respiratory, thoracic and mediastinal disorders
Nasal congestion	0/49 (0%)	0	2/46 (4.3%)	2
Hiccup	1/49 (2%)	1	0/46 (0%)	0
Hyperventilation	0/49 (0%)	0	1/46 (2.2%)	1
Skin and subcutaneous tissue disorders
Cellulitis	1/49 (2%)	1	0/46 (0%)	0
Rash	2/49 (4.1%)	2	1/46 (2.2%)	1
Vascular disorders
Hot flashes	1/49 (2%)	1	1/46 (2.2%)	1
Hypertension	3/49 (6.1%)	3	2/46 (4.3%)	2
Tachycardia	5/49 (10.2%)	10	0/46 (0%)	0

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.