Efficacy and Feasibility of a Personalized Treatment for Depression With Co-Occurring Anxiety

• Sponsor: University of Pittsburgh (Other)
• Overall Status: Completed
• CT.gov ID: NCT00930293
• Collaborator: National Institute of Mental Health (NIMH) (NIH)
• Enrollment: 50
• Location: 1
• Arms: 2
• Duration (Months): 35
• Patients Per Site Per Month: 1.4

Study Details

Study Description

Brief Summary

This study will examine the feasibility and efficacy of a personalized psychotherapy treatment for people with depression and co-occurring anxiety.

Condition or Disease	Intervention/Treatment	Phase
Depression; Anxiety	Behavioral: Interpersonal Psychotherapy for Depression with Panic and Anxiety Symptoms (IPT-PS); Behavioral: Brief Supportive Psychotherapy (BSP); Drug: Citalopram hydrobromide	N/A

Detailed Description

Approximately one half of all depressed psychiatric patients also meet the criteria for an anxiety disorder. Compared to people with only depression, people with both depression and panic features experience poorer psychological and social functioning, a greater risk of suicide, less response to medication and therapy treatment, and a greater risk of recurring symptoms. Because people with depression and co-occurring anxiety features do not achieve full symptom remission with either medication or therapy alone, this study will use a treatment that combines the two. A commonly used type of depression medication called a selective serotonin reuptake inhibitor (SSRI) will be combined with a specialized therapy developed to address depression with co-occurring symptoms of panic, anxiety, and avoidance. This study will also test a computer-based method of assessing mood and anxiety symptom profiles and outcomes to determine whether participants find this method acceptable and clinicians find it useful.

Participation in this study will last 20 weeks, with follow-up visits occurring 4 and 8 months after starting. Participants will be randomly assigned to receive either an individualized therapy for depression and anxiety, called interpersonal psychotherapy for depression with panic and anxiety symptoms (IPT-PS), or a standard therapy for depression, called brief supportive psychotherapy (BSP). All participants will complete up to 16 therapy sessions and receive a standard SSRI treatment with the medication citalopram hydrobromide. During the IPT-PS treatment, a study therapist will examine regular computer updates of depression and anxiety scores for participants and talk to them about identifying and addressing life stressors that trigger symptoms. During the BSP treatment, a study therapist will encourage participants to arrive at their own solutions by emphasizing the participants' strengths and examining what has worked in the past.

Participants will complete assessments weekly during the 20 weeks of the study intervention and at 4- and 8-month follow-up visits. These assessments will include self-report questionnaires about symptoms, medication side effects, and treatment adherence; vital sign and weight measurements; and a clinical interview. Regular assessments of medication effectiveness and side effects will occur every 1 to 4 weeks. Starting at the second study visit, participants will also complete monthly computer-based questionnaires about depression and anxiety symptoms.

Study Design

• Study Type: Interventional
• Actual Enrollment: 50 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Personalizing Treatment of Depression Complicated by Panic Features-Pilot Study
• Study Start Date: Jul 1, 2009
• Actual Primary Completion Date: Jun 1, 2012
• Actual Study Completion Date: Jun 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Personalized Depression Care Participants will receive interpersonal psychotherapy for depression with panic and anxiety symptoms (IPT-PS) and standard antidepressant medication (citalopram) treatment.	Behavioral: Interpersonal Psychotherapy for Depression with Panic and Anxiety Symptoms (IPT-PS); 16 weekly IPT-PS sessions, each lasting approximately 45 minutes; Drug: Citalopram hydrobromide; A 20-week regimen of citalopram hydrobromide monotherapy on a flexible dosing schedule ranging from 10 to 60 mg/day; Other Names: Celexa
Active Comparator: Standard Depression Care Participants will receive brief supportive psychotherapy (BSP) and standard antidepressant medication (citalopram) treatment.	Behavioral: Brief Supportive Psychotherapy (BSP); 16 weekly BPS sessions, each lasting approximately 45 minutes; Drug: Citalopram hydrobromide; A 20-week regimen of citalopram hydrobromide monotherapy on a flexible dosing schedule ranging from 10 to 60 mg/day; Other Names: Celexa

Outcome Measures

Primary Outcome Measures

1. Number of Participants Meeting Depression Remission Criteria [Measured at baseline and weekly for up to 20 weeks of acute treatment]

   Depression remission defined as 3 consecutive weeks of HRSD-17 scores that on average, < or = 7

Secondary Outcome Measures

1. Weeks to Depression Remission [Measured at baseline and weekly for up to 20 weeks of treatment]

   Kaplan-Meier survival analyses to determine time to depression remission (defined as average HRSD-17 score < or = 7 for three consecutive weeks). Analyses run with the full intent to treat sample (censoring patients who dropped out at time of termination)

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Currently in an episode of nonpsychotic major depression, as defined by the DSM-IV and documented by both the Structured Clinical Interview for Axis I, DSM-IV Disorders (SCID) and by a rating of greater than 15 on the 25-item Hamilton Rating Scale for Depression (HRSD)

• Panic spectrum risk category of at least 7, as defined by the Panic-Agoraphobic Spectrum Self-Report (PAS-SR), last month version

• Not currently receiving effective treatment

• Participants with suicidal ideation are eligible as long as outpatient treatment is deemed safe.

Exclusion Criteria:

• History of manic or hypomanic episode(s)

• History of schizophrenia or schizoaffective disorder

• Mood disorder due to a general medical condition or induced by substance use

• Presence of psychosis

• Current pregnancy or plans to become pregnant

• Current primary diagnosis of anorexia nervosa or bulimia nervosa (this does not include an eating disorder not otherwise specified [NOS])

• Current primary diagnosis of severe obsessive-compulsive disorder (OCD), as determined by clinician evaluation of symptom severity and temporal onset of symptoms

• Drug or alcohol abuse or dependence within the past 3 months (participants with episodic abuse related to mood episodes will not be excluded)

• Satisfies full DSM-IV criteria for antisocial personality disorder, as determined by SCID-II evaluation

• Requires inpatient treatment because of suicidal risk or psychotic symptoms (current suicidal thinking or parasuicidal behavior is not exclusionary if, in clinician judgment, it can be managed on an outpatient basis)

• Any of the following medical conditions:

1. An index episode that is secondary to the effect of medically prescribed drugs, i.e., reserpine, antihistamines, etc.

2. Presence of significant uncontrolled medical illness including cardiovascular disorder, kidney or liver disease, epilepsy, untreated hypertension, or unstabilized endocrine disease (stable medical conditions such as well-controlled diabetes or HIV positive status are not exclusionary provided the participant meets other inclusion and exclusion criteria)

3. Current treatment with a pharmacologic, over-the-counter, or herbal therapy for depression or anxiety (unless the participant wishes to discontinue an ineffective treatment)

• History of poor or failed treatment response to an adequate dose and duration of citalopram

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Western Psychiatric Institute and Clinic	Pittsburgh	Pennsylvania	United States	15213

Sponsors and Collaborators

• University of Pittsburgh
• National Institute of Mental Health (NIMH)

Investigators

• Principal Investigator: Jill M. Cyranowski, PhD, University of Pittsburgh

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Jill Cyranowski, Associate Professor of Psychiatry and Psychology, University of Pittsburgh
• ClinicalTrials.gov Identifier: NCT00930293
• Other Study ID Numbers: R01MH085874; R01MH085874; MH085874-01; PRO08070009; PCC: DSIR 84-CT
• First Posted: Jun 30, 2009
• Last Update Posted: Feb 9, 2016
• Last Verified: Jan 1, 2016

• Keywords provided by Jill Cyranowski, Associate Professor of Psychiatry and Psychology, University of Pittsburgh: Interpersonal Psychotherapy
• Additional relevant MeSH terms: Depression; Depressive Disorder; Dexetimide; Citalopram

Study Results

Participant Flow

Arm/Group Title	Personalized Depression Care	Standard Depression Care
Arm/Group Description	Participants will receive interpersonal psychotherapy for depression with panic and anxiety symptoms (IPT-PS) and standard antidepressant medication treatment. Interpersonal Psychotherapy for Depression with Panic and Anxiety Symptoms (IPT-PS): 16 weekly IPT-PS sessions, each lasting approximately 45 minutes Citalopram hydrobromide: A 20-week regimen of citalopram hydrobromide monotherapy on a flexible dosing schedule ranging from 10 to 60 mg/day	Participants will receive brief supportive psychotherapy (BSP) and standard antidepressant medication treatment. Brief Supportive Psychotherapy (BSP): 16 weekly BPS sessions, each lasting approximately 45 minutes Citalopram hydrobromide: A 20-week regimen of citalopram hydrobromide monotherapy on a flexible dosing schedule ranging from 10 to 60 mg/day
Period Title: Overall Study
STARTED	24	26
COMPLETED	17	19
NOT COMPLETED	7	7

Baseline Characteristics

Arm/Group Title	Personalized Depression Care	Standard Depression Care	Total
Arm/Group Description	Participants will receive interpersonal psychotherapy for depression with panic and anxiety symptoms (IPT-PS) and standard antidepressant medication treatment. Interpersonal Psychotherapy for Depression with Panic and Anxiety Symptoms (IPT-PS): 16 weekly IPT-PS sessions, each lasting approximately 45 minutes Citalopram hydrobromide: A 20-week regimen of citalopram hydrobromide monotherapy on a flexible dosing schedule ranging from 10 to 60 mg/day	Participants will receive brief supportive psychotherapy (BSP) and standard antidepressant medication treatment. Brief Supportive Psychotherapy (BSP): 16 weekly BPS sessions, each lasting approximately 45 minutes Citalopram hydrobromide: A 20-week regimen of citalopram hydrobromide monotherapy on a flexible dosing schedule ranging from 10 to 60 mg/day	Total of all reporting groups
Overall Participants	24	26	50
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	30.37 (11.41)	31.09 (10.27)	30.74 (10.72)
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	24 100%	26 100%	50 100%
>=65 years	0 0%	0 0%	0 0%
Sex: Female, Male (Count of Participants)
Female	19 79.2%	18 69.2%	37 74%
Male	5 20.8%	8 30.8%	13 26%
Region of Enrollment (participants) [Number]
United States	24 100%	26 100%	50 100%

Outcome Measures

1. Primary Outcome

Title	Number of Participants Meeting Depression Remission Criteria
Description	Depression remission defined as 3 consecutive weeks of HRSD-17 scores that on average, < or = 7
Time Frame	Measured at baseline and weekly for up to 20 weeks of acute treatment

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Personalized Depression Care	Standard Depression Care
Arm/Group Description	Participants will receive interpersonal psychotherapy for depression with panic and anxiety symptoms (IPT-PS) and standard antidepressant medication treatment. Interpersonal Psychotherapy for Depression with Panic and Anxiety Symptoms (IPT-PS): 16 weekly IPT-PS sessions, each lasting approximately 45 minutes Citalopram hydrobromide: A 20-week regimen of citalopram hydrobromide monotherapy on a flexible dosing schedule ranging from 10 to 60 mg/day	Participants will receive brief supportive psychotherapy (BSP) and standard antidepressant medication treatment. Brief Supportive Psychotherapy (BSP): 16 weekly BPS sessions, each lasting approximately 45 minutes Citalopram hydrobromide: A 20-week regimen of citalopram hydrobromide monotherapy on a flexible dosing schedule ranging from 10 to 60 mg/day
Measure Participants	24	26
Number [participants]	10 41.7%	15 57.7%

2. Secondary Outcome

Title	Weeks to Depression Remission
Description	Kaplan-Meier survival analyses to determine time to depression remission (defined as average HRSD-17 score < or = 7 for three consecutive weeks). Analyses run with the full intent to treat sample (censoring patients who dropped out at time of termination)
Time Frame	Measured at baseline and weekly for up to 20 weeks of treatment

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Personalized Depression Care	Standard Depression Care
Arm/Group Description	Participants will receive interpersonal psychotherapy for depression with panic and anxiety symptoms (IPT-PS) and standard antidepressant medication treatment. Interpersonal Psychotherapy for Depression with Panic and Anxiety Symptoms (IPT-PS): 16 weekly IPT-PS sessions, each lasting approximately 45 minutes Citalopram hydrobromide: A 20-week regimen of citalopram hydrobromide monotherapy on a flexible dosing schedule ranging from 10 to 60 mg/day	Participants will receive brief supportive psychotherapy (BSP) and standard antidepressant medication treatment. Brief Supportive Psychotherapy (BSP): 16 weekly BPS sessions, each lasting approximately 45 minutes Citalopram hydrobromide: A 20-week regimen of citalopram hydrobromide monotherapy on a flexible dosing schedule ranging from 10 to 60 mg/day
Measure Participants	24	26
Mean (Standard Error) [weeks]	13.99 (1.47)	11.59 (1.31)

Adverse Events

Arm/Group Title	Personalized Depression Care		Standard Depression Care
Arm/Group Description	Participants will receive interpersonal psychotherapy for depression with panic and anxiety symptoms (IPT-PS) and standard antidepressant medication treatment. Interpersonal Psychotherapy for Depression with Panic and Anxiety Symptoms (IPT-PS): 16 weekly IPT-PS sessions, each lasting approximately 45 minutes Citalopram hydrobromide: A 20-week regimen of citalopram hydrobromide monotherapy on a flexible dosing schedule ranging from 10 to 60 mg/day		Participants will receive brief supportive psychotherapy (BSP) and standard antidepressant medication treatment. Brief Supportive Psychotherapy (BSP): 16 weekly BPS sessions, each lasting approximately 45 minutes Citalopram hydrobromide: A 20-week regimen of citalopram hydrobromide monotherapy on a flexible dosing schedule ranging from 10 to 60 mg/day
All Cause Mortality
	Personalized Depression Care		Standard Depression Care
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Personalized Depression Care		Standard Depression Care
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/24 (0%)		0/26 (0%)
Other (Not Including Serious) Adverse Events
	Personalized Depression Care		Standard Depression Care
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/24 (0%)		1/26 (3.8%)
General disorders
Unexplained Visual Disturbance	0/24 (0%)	0	1/26 (3.8%)	1

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE 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.