Escitalopram in the Treatment of Dysthymic Disorder, Double Blind
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 |
---|---|---|
|
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
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:
|
Placebo Comparator: Placebo inactive comparator |
Drug: Lexapro (escitalopram)
antidepressant drug selective serotonin reuptake inhibitor (SSRI)
Other Names:
|
Outcome Measures
Primary Outcome Measures
- 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)
- 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
- 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)
- 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.
- Clinical Global Impressions - Severity (CGI-S) [Baseline]
Clinician rated severity, score on CGI-S scale ranging from 1 (no pathology) to 7 (extreme pathology)
- 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
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:
Publications
None provided.- LXP-MD-34
Study Results
Participant Flow
Recruitment Details | |
---|---|
Pre-assignment Detail |
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
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 |
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)
|
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)
|
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)
|
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)
|
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. | |||
---|---|---|---|---|
Adverse Event Reporting Description | ||||
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
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.
Results Point of Contact
Name/Title | David Hellerstein MD |
---|---|
Organization | NY State Psychiatric Institute |
Phone | 6467748000 |
hellers@nyspi.columbia.edu |
- LXP-MD-34