Dysthymic Disorder
Conditions
Keywords
Dysthymic Disorder, Depression, Chronic Depression, Escitalopram
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.
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.
Interventions
DRUGLexapro (escitalopram)
antidepressant drug selective serotonin reuptake inhibitor (SSRI)
Sponsors
Forest Laboratories
St. Luke's-Roosevelt Hospital Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Escitalopram 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) | 17 |
| Placebo inactive comparator
Lexapro (escitalopram): antidepressant drug selective serotonin reuptake inhibitor (SSRI) | 17 |
| Total | 34 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 5 | 4 |
Baseline characteristics
| Characteristic | Escitalopram | Placebo | Total |
|---|---|---|---|
| Age, Continuous | 43.88 years STANDARD_DEVIATION 9.92 | 43.59 years STANDARD_DEVIATION 11.33 | 43.74 years STANDARD_DEVIATION 10.49 |
| Sex: Female, Male Female | 6 Participants | 11 Participants | 17 Participants |
| Sex: Female, Male Male | 11 Participants | 6 Participants | 17 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 15 / 17 | 14 / 15 |
| serious Total, serious adverse events | 0 / 17 | 0 / 17 |
Outcome results
Primary
Hamilton-Depression Rating Scale (HDRS-24 Items)
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Escitalopram | Hamilton-Depression Rating Scale (HDRS-24 Items) | 10.88 units on a scale | Standard Deviation 5.83 |
| Placebo | Hamilton-Depression Rating Scale (HDRS-24 Items) | 16.41 units on a scale | Standard Deviation 6.34 |
p-value: 0.1Repeated Measures ANOVA
Primary
Hamilton-Depression Rating Scale (HDRS-24 Items)
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Escitalopram | Hamilton-Depression Rating Scale (HDRS-24 Items) | 22.82 units on a scale | Standard Deviation 5.75 |
| Placebo | Hamilton-Depression Rating Scale (HDRS-24 Items) | 24.41 units on a scale | Standard Deviation 6.25 |
Secondary
Beck Depression Inventory (BDI)
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Escitalopram | Beck Depression Inventory (BDI) | 15.00 units on a scale | Standard Deviation 5.21 |
| Placebo | Beck Depression Inventory (BDI) | 16.25 units on a scale | Standard Deviation 5.12 |
Secondary
Beck Depression Inventory (BDI)
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Escitalopram | Beck Depression Inventory (BDI) | 6.76 units on a scale | Standard Deviation 4.91 |
| Placebo | Beck Depression Inventory (BDI) | 10.00 units on a scale | Standard Deviation 5.16 |
Secondary
Clinical Global Impressions - Severity (CGI-S)
Clinician rated severity, score on CGI-S scale ranging from 1 (no pathology) to 7 (extreme pathology)
Time frame: Week 12
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Escitalopram | Clinical Global Impressions - Severity (CGI-S) | 2.35 units on a scale | Standard Deviation 0.93 |
| Placebo | Clinical Global Impressions - Severity (CGI-S) | 3.41 units on a scale | Standard Deviation 1.06 |
Secondary
Clinical Global Impressions - Severity (CGI-S)
Clinician rated severity, score on CGI-S scale ranging from 1 (no pathology) to 7 (extreme pathology)
Time frame: Baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Escitalopram | Clinical Global Impressions - Severity (CGI-S) | 4.06 units on a scale | Standard Deviation 0.24 |
| Placebo | Clinical Global Impressions - Severity (CGI-S) | 4.06 units on a scale | Standard Deviation 0.43 |