Escitalopram in the Treatment of Dysthymic Disorder, Double Blind

• Sponsor: St. Luke's-Roosevelt Hospital Center (Other)
• Overall Status: Completed
• CT.gov ID: NCT00220701
• Collaborator: Forest Laboratories (Industry)
• Enrollment: 36
• Location: 1
• Arms: 2
• Duration (Months): 79
• Patients Per Site Per Month: 0.5

Study Details

Study Description

Brief Summary

This is a 12-week double-blind placebo-controlled study of Escitalopram in treatment of dysthymic Disorder (low-grade chronic depression), with a 12 week open-label extension phase.

It is hypothesized that Escitalopram will be superior to placebo in improving depression, as well as psychosocial, temperamental, and cognitive functioning.

Condition or Disease	Intervention/Treatment	Phase
Dysthymic Disorder	Drug: Lexapro (escitalopram)	Phase 4

Detailed Description

This is a 12-week double-blind placebo-controlled study of Escitalopram in treatment of Dysthymic Disorder (low-grade chronic depression), with a 12 week open-label extension phase.

Flexible dosing to a maximum of 40 mg per day will be used. It is hypothesized that Escitalopram will be superior to placebo in improving depression, as well as psychosocial, temperamental, and cognitive functioning. Blood cytokine levels will also be measured at weeks 0, 12, and 24 to determine their relationship to depressive symptoms and improvement.

Study Design

• Study Type: Interventional
• Actual Enrollment: 36 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Double-Blind Placebo-Controlled Study of Escitalopram in the Treatment of Dysthymic Disorder
• Study Start Date: Jun 1, 2002
• Actual Primary Completion Date: Nov 1, 2008
• Actual Study Completion Date: Jan 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
Experimental: escitalopram Escitalopram (brand name Lexapro) is an antidepressant medication taken once per day, dosing from 10 to 20 milligrams per day.	Drug: Lexapro (escitalopram); antidepressant drug selective serotonin reuptake inhibitor (SSRI); Other Names: lexapro escitalopram s-citalopram d-citalopram
Placebo Comparator: Placebo inactive comparator	Drug: Lexapro (escitalopram); antidepressant drug selective serotonin reuptake inhibitor (SSRI); Other Names: lexapro escitalopram s-citalopram d-citalopram

Outcome Measures

Primary Outcome Measures

1. Hamilton-Depression Rating Scale (HDRS-24 Items) [Week 12]

   Clinician rated measure of depression, mean score; This study used the 24 item version of the Hamilton Depression Rating Scale; item scores range from 0 to 4 on some items, 0 to 2 or 0 to 3 on other items; range of total score = 0 to 75, with higher score indicating worse depression Response (>50% decrease) Remission (score<=7)

2. Hamilton-Depression Rating Scale (HDRS-24 Items) [Baseline]

   Clinician rated measure of depression, mean score; This study used the 24 item version of the Hamilton Depression Rating Scale; item scores range from 0 to 4 on some items, 0 to 2 or 0 to 3 on other items; range of total score = 0 to 75, with higher score indicating worse depression Response (>50% decrease) Remission (score<=7)

Secondary Outcome Measures

1. Clinical Global Impressions - Severity (CGI-S) [Week 12]

   Clinician rated severity, score on CGI-S scale ranging from 1 (no pathology) to 7 (extreme pathology)

2. Beck Depression Inventory (BDI) [Baseline]

   21 item patient rated assessment of depression symptoms, with item scores ranging from 0 to 3. Total BDI scores can range from 0 to 63, with higher scores indicating worse depression.

3. Clinical Global Impressions - Severity (CGI-S) [Baseline]

   Clinician rated severity, score on CGI-S scale ranging from 1 (no pathology) to 7 (extreme pathology)

4. Beck Depression Inventory (BDI) [Week 12]

   21 item patient rated assessment of depression symptoms, with item scores ranging from 0 to 3. Total BDI scores can range from 0 to 63, with higher scores indicating worse depression.

Eligibility Criteria

Criteria

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

Inclusion Criteria:

• Male and female outpatients 18-65 years of age.

• Patients with a Diagnostic and Statistical Manual, fourth edition (DSM-IV) diagnosis of dysthymic disorder.

• Subject must be considered reliable.

• Patients will have a total of 12 or higher on the Hamilton Depression Scale (24 items) at baseline.

Exclusion Criteria:

• Patients with a DSM-IV diagnosis of Delirium, Dementia, and Amnestic, and other Cognitive Disorders.

• Patients who plan to produce a pregnancy within the next 6 months, or patients who are pregnant or nursing women.

• Patients who have a history of non-response to two or more sufficient trials of antidepressant medication (as defined in Table 1).

• Patients with a principal diagnosis meeting DSM-IV criteria for:

• Major Depressive Disorder, current

• Bipolar Disorder or cyclothymia .Schizophrenia, Delusional (Paranoid) Disorders and Psychotic Disorders not elsewhere classified.

• Anorexia Nervosa or Bulimia

• Patients who, within the past 6 months, met DSM-IV criteria for abuse of or dependence on any drug, including alcohol, excluding caffeine and tobacco.

• Patients who have taken psychotropic medication or herbal preparations with putative psychotropic effects within 7 days prior to Visit 2. Patients taking a monoamine oxidase inhibitor (a type of antidepressant) (MAOI) must have a washout period of 14 days prior to visit 2, and patients taking fluoxetine must have a washout period of at least 4 weeks prior to Visit 2.

• Patients who would pose a serious risk for suicide during the course of the study, as evidenced by one of the following:

• Report of having a specific plan for killing themselves

• A score of 3 or higher on the Hamilton Depression Rating Scale item #3 as rated by the treating clinician at Week 0, (indicative of active suicidal thoughts or behaviors)

• A suicide attempt within the past 12 months requiring emergency room visit, medical or psychiatric hospitalization, or otherwise deemed to be life-threatening (e.g. an overdose of > 1 week's dose of medication.

• Patients with unstable medical conditions, such as acute hyperthyroidism, uncorrected hypothyroidism, undiagnosed fever, uncontrolled angina, or any other serious medical illness, including any cardiovascular, hepatic, respiratory, hematological, endocrinologic o neurologic disease, or any clinically significant laboratory abnormality.

• Patients who lack the capacity to proved informed consent

• 50% or greater decrease in HDRS total score from visit 2 to visit 3 or a CGI-Improvement score of 1 ("very much improved") or 2 ("much improved") at Visit 3

• Patients receiving CGI Improvement scores of 6 ("much worse") or 7 ("very much worse") for two consecutive visits will be withdrawn from the study.

• Patients who meet criteria for Major Depressive Disorder at any time during the course of the study will be withdrawn from the study.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Mood Disorders Research Program, St. Luke's-Roosevelt Hospital Center	New York	New York	United States	10019

Sponsors and Collaborators

• St. Luke's-Roosevelt Hospital Center
• Forest Laboratories

Investigators

• Principal Investigator: David J. Hellerstein, MD, St. Luke's-Roosevelt Hospital, and NY State Psychiatric Institute

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• For more information about our program and this study click here.

Publications

None provided.

• Responsible Party: St. Luke's-Roosevelt Hospital Center
• ClinicalTrials.gov Identifier: NCT00220701
• Other Study ID Numbers: LXP-MD-34
• First Posted: Sep 22, 2005
• Last Update Posted: Nov 11, 2015
• Last Verified: Nov 1, 2007

• Keywords provided by St. Luke's-Roosevelt Hospital Center: Dysthymic Disorder; Depression; Chronic Depression; Escitalopram
• Additional relevant MeSH terms: Disease; Dysthymic Disorder; Dexetimide; Citalopram

Study Results

Participant Flow

Arm/Group Title	Escitalopram	Placebo
Arm/Group Description	Escitalopram (brand name Lexapro) is an antidepressant medication taken once per day, dosing from 10 to 20 milligrams per day. Lexapro (escitalopram): antidepressant drug selective serotonin reuptake inhibitor (SSRI)	inactive comparator Lexapro (escitalopram): antidepressant drug selective serotonin reuptake inhibitor (SSRI)
Period Title: Overall Study
STARTED	17	17
COMPLETED	12	13
NOT COMPLETED	5	4

Baseline Characteristics

Arm/Group Title	Escitalopram	Placebo	Total
Arm/Group Description	Escitalopram (brand name Lexapro) is an antidepressant medication taken once per day, dosing from 10 to 20 milligrams per day. Lexapro (escitalopram): antidepressant drug selective serotonin reuptake inhibitor (SSRI)	inactive comparator Lexapro (escitalopram): antidepressant drug selective serotonin reuptake inhibitor (SSRI)	Total of all reporting groups
Overall Participants	17	17	34
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	43.88 (9.92)	43.59 (11.33)	43.74 (10.49)
Sex: Female, Male (Count of Participants)
Female	6 35.3%	11 64.7%	17 50%
Male	11 64.7%	6 35.3%	17 50%

Outcome Measures

1. Primary Outcome

Title	Hamilton-Depression Rating Scale (HDRS-24 Items)
Description	Clinician rated measure of depression, mean score; This study used the 24 item version of the Hamilton Depression Rating Scale; item scores range from 0 to 4 on some items, 0 to 2 or 0 to 3 on other items; range of total score = 0 to 75, with higher score indicating worse depression Response (>50% decrease) Remission (score<=7)
Time Frame	Week 12

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Escitalopram	Placebo
Arm/Group Description	Escitalopram (brand name Lexapro) is an antidepressant medication taken once per day, dosing from 10 to 20 milligrams per day. Lexapro (escitalopram): antidepressant drug selective serotonin reuptake inhibitor (SSRI)	inactive comparator Lexapro (escitalopram): antidepressant drug selective serotonin reuptake inhibitor (SSRI)
Measure Participants	17	17
Mean (Standard Deviation) [units on a scale]	10.88 (5.83)	16.41 (6.34)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Escitalopram, Placebo
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.10
	Comments
	Method	Repeated Measures ANOVA
	Comments
Method of Estimation	Estimation Parameter	F statistics
	Estimated Value	2.82
	Confidence Interval	(2-Sided) %; to
	Parameter Dispersion	Type: Value:
	Estimation Comments

2. Secondary Outcome

Title	Clinical Global Impressions - Severity (CGI-S)
Description	Clinician rated severity, score on CGI-S scale ranging from 1 (no pathology) to 7 (extreme pathology)
Time Frame	Week 12

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Escitalopram	Placebo
Arm/Group Description	Escitalopram (brand name Lexapro) is an antidepressant medication taken once per day, dosing from 10 to 20 milligrams per day. Lexapro (escitalopram): antidepressant drug selective serotonin reuptake inhibitor (SSRI)	inactive comparator Lexapro (escitalopram): antidepressant drug selective serotonin reuptake inhibitor (SSRI)
Measure Participants	17	17
Mean (Standard Deviation) [units on a scale]	2.35 (0.93)	3.41 (1.06)

3. Secondary Outcome

Title	Beck Depression Inventory (BDI)
Description	21 item patient rated assessment of depression symptoms, with item scores ranging from 0 to 3. Total BDI scores can range from 0 to 63, with higher scores indicating worse depression.
Time Frame	Baseline

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Escitalopram	Placebo
Arm/Group Description	Escitalopram (brand name Lexapro) is an antidepressant medication taken once per day, dosing from 10 to 20 milligrams per day. Lexapro (escitalopram): antidepressant drug selective serotonin reuptake inhibitor (SSRI)	inactive comparator Lexapro (escitalopram): antidepressant drug selective serotonin reuptake inhibitor (SSRI)
Measure Participants	17	17
Mean (Standard Deviation) [units on a scale]	15.00 (5.21)	16.25 (5.12)

4. Primary Outcome

Title	Hamilton-Depression Rating Scale (HDRS-24 Items)
Description	Clinician rated measure of depression, mean score; This study used the 24 item version of the Hamilton Depression Rating Scale; item scores range from 0 to 4 on some items, 0 to 2 or 0 to 3 on other items; range of total score = 0 to 75, with higher score indicating worse depression Response (>50% decrease) Remission (score<=7)
Time Frame	Baseline

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Escitalopram	Placebo
Arm/Group Description	Escitalopram (brand name Lexapro) is an antidepressant medication taken once per day, dosing from 10 to 20 milligrams per day. Lexapro (escitalopram): antidepressant drug selective serotonin reuptake inhibitor (SSRI)	inactive comparator Lexapro (escitalopram): antidepressant drug selective serotonin reuptake inhibitor (SSRI)
Measure Participants	17	17
Mean (Standard Deviation) [units on a scale]	22.82 (5.75)	24.41 (6.25)

5. Secondary Outcome

Title	Clinical Global Impressions - Severity (CGI-S)
Description	Clinician rated severity, score on CGI-S scale ranging from 1 (no pathology) to 7 (extreme pathology)
Time Frame	Baseline

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Escitalopram	Placebo
Arm/Group Description	Escitalopram (brand name Lexapro) is an antidepressant medication taken once per day, dosing from 10 to 20 milligrams per day. Lexapro (escitalopram): antidepressant drug selective serotonin reuptake inhibitor (SSRI)	inactive comparator Lexapro (escitalopram): antidepressant drug selective serotonin reuptake inhibitor (SSRI)
Measure Participants	17	17
Mean (Standard Deviation) [units on a scale]	4.06 (0.24)	4.06 (0.43)

6. Secondary Outcome

Title	Beck Depression Inventory (BDI)
Description	21 item patient rated assessment of depression symptoms, with item scores ranging from 0 to 3. Total BDI scores can range from 0 to 63, with higher scores indicating worse depression.
Time Frame	Week 12

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Escitalopram	Placebo
Arm/Group Description	Escitalopram (brand name Lexapro) is an antidepressant medication taken once per day, dosing from 10 to 20 milligrams per day. Lexapro (escitalopram): antidepressant drug selective serotonin reuptake inhibitor (SSRI)	inactive comparator Lexapro (escitalopram): antidepressant drug selective serotonin reuptake inhibitor (SSRI)
Measure Participants	17	17
Mean (Standard Deviation) [units on a scale]	6.76 (4.91)	10.00 (5.16)

Adverse Events

Time Frame	Participants were evaluated weekly for the first two weeks after randomization and then biweekly thereafter till week 12.
Arm/Group Title	Escitalopram		Placebo
Arm/Group Description	Escitalopram (brand name Lexapro) is an antidepressant medication taken once per day, dosing from 10 to 20 milligrams per day. Lexapro (escitalopram): antidepressant drug selective serotonin reuptake inhibitor (SSRI)		inactive comparator Lexapro (escitalopram): antidepressant drug selective serotonin reuptake inhibitor (SSRI)
All Cause Mortality
	Escitalopram		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Escitalopram		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/17 (0%)		0/17 (0%)
Other (Not Including Serious) Adverse Events
	Escitalopram		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	15/17 (88.2%)		14/15 (93.3%)
Gastrointestinal disorders
Upset stomach	0/17 (0%)	0	3/15 (20%)	3
General disorders
Other	3/17 (17.6%)	3	10/15 (66.7%)	10
Nervous system disorders
Lightheadedness	3/17 (17.6%)	3	0/15 (0%)	0
Reproductive system and breast disorders
Decreased Libido	6/17 (35.3%)	6	1/15 (6.7%)	1
Delayed Ejection	3/17 (17.6%)	3	0/15 (0%)	0

Limitations/Caveats

Small double blinded study with limited power.

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.