Dysthymic Disorder Clinical Trial
Official title:
Duloxetine for Chronic Depression: a Double-blind Study
The investigators are studying a new antidepressant medicine, duloxetine, for the treatment
of people with chronic depression. Duloxetine (trade name Cymbalta) was recently approved by
the FDA for the treatment of major depression. The investigators are testing whether this
medicine is also effective for adults with chronic depression (dysthymic disorder or
dysthymia).
Chronic depression, lasting two or more years, often causes significant suffering and
impairment. The investigators study involves a 6 to 10 week double-blind Initial Phase
during which half of the participants will take the new medication and half will take a
placebo (an inactive look-alike pill). After the Initial Phase, a 12-week Continuation Phase
will begin, during which all subjects can be treated with an FDA-approved antidepressant
medication.
Eligible subjects may also receive MRI scans, to help the investigators understand how
antidepressants work in treating depression.
Status | Completed |
Enrollment | 65 |
Est. completion date | December 2013 |
Est. primary completion date | December 2011 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 20 Years to 75 Years |
Eligibility |
Inclusion Criteria: - age 20 to 75 years (ages 20 to 60 for MRI sub-study) - diagnosis of dysthymic disorder (chronic depression) or depression NOS - minimum of 2 years duration of current episode of depression Exclusion Criteria: - current major depression - diagnoses including delirium, dementia, bipolar disorder, schizophrenia - substance abuse or dependence in the past 6 months - pregnant or nursing women - serious risk of suicide |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | New York State Psychiatric Institute | New York | New York |
Lead Sponsor | Collaborator |
---|---|
New York State Psychiatric Institute | Eli Lilly and Company |
United States,
Hellerstein DJ, Stewart JW, McGrath PJ, Deliyannides DA, Batchelder ST, Black SR, Withers A, O'Shea D, Chen Y. A randomized controlled trial of duloxetine versus placebo in the treatment of nonmajor chronic depression. J Clin Psychiatry. 2012 Jul;73(7):98 — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Hamilton Depression Rating Scale (HDRS) - 24 Total Score | HDRS-24 total score, standardly used rating scale for depression. Score 0-7 no depression; Score 8-16 mild depression; Score 17-23 moderate depression; Score 24 and up severe depression. Range= 0 to 75, higher score=worse depression | Week 10 | Yes |
Primary | Hamilton Depression Rating Scale (HDRS) - 24 Total Score | HDRS-24 total score, standardly used rating scale for depression. Score 0-7 no depression; Score 8-16 mild depression; Score 17-23 moderate depression; Score 24 and up severe depression. Range= 0 to 75, higher score=worse depression | Baseline | Yes |
Secondary | Cornell Dysthymia Rating Scale (CDRS) | CDRS is a 20-item clinician-rated inventory for chronic depressive symptoms. Each item was characterized by an explanatory or illustrative description and rated from 0 (symptom absent) to 4 (severe symptoms). Scores from 0 to 82 with higher score indicating worse depression |
Week 10 | No |
Secondary | Global Assessment of Functioning Scale (GAF) | A commonly used rating scale for global social function. Range from 0 to 100; higher score=better functioning. 91 - 100 No symptoms. 81 - 90 Absent or minimal symptoms 71 - 80 no more than slight impairment in social, occupational, or school functioning (e.g., temporarily falling behind in schoolwork). 61 - 70 Some mild symptoms 51 - 60 Moderate symptoms 41 - 50 Serious symptoms 31 - 40 Some impairment in reality testing or communication 21 - 30 Behavior is considerably influenced by delusions or hallucinations or serious impairment, in communication or judgment 11 - 20 Some danger of hurting self or others 1 - 10 Persistent danger of severely hurting self or others or persistent inability to maintain minimal personal hygiene or serious suicidal act with clear expectation of death. 0 Inadequate information |
Week 10 | No |
Secondary | Beck Depression Inventory (BDI) | Beck Depression Inventory (BDI)is a 21-question multiple-choice self-report inventory, one of the most widely used instruments for measuring the severity of depression. When the test is scored, a value of 0 to 3 is assigned for each answer and then the total score is compared to a key to determine the depression's severity. The standard cut-offs are as follows:[7] 0-9: indicates minimal depression 10-18: indicates mild depression 19-29: indicates moderate depression 30-63: indicates severe depression. Higher total scores indicate more severe depressive symptoms. |
Week 10 | No |
Secondary | Magnetic Resonance Imaging, Anatomical | Chronic depression vs. normal differences: we expect to find abnormal brain region volumes in several regions compared to norms. Specifically: Frontal Cortex: decreased dorsal prefrontal volume, and reduced grey matter in subgenual prefrontal cortex; reduced orbitofrontal cortex gray matter volume; decreased hippocampal volume; decreased amygdala volume; decreased caudate volume; decreased putamen volume treatment vs. placebo differences: following active treatment, we hypothesize that volumes will change in the direction of normal in the hippocampus, prefrontal cortex, subgenual cortex, and amygdala responder vs. non-responder differences: greater changes in the areas found in hypothesis 2 are expected in treatment responders compared to non-responders |
10 weeks, 22 weeks | No |
Secondary | Clinical Global Impressions Improvement(CGI-I) | The Clinical Global Impression - Improvement(CGI-I) is a 7-point scale that rate patient's total improvement whether or not comparing to his/her condition at baseline. 0 = Not assessed = Very much improved = Much improved = Minimally improved = No change = Minimally worse = Much worse = Very much worse Higher score=greatest worsening |
10 weeks | No |
Secondary | Magnetic Resonance Imaging, Functional (fMRI) | Functional brain imaging tests, including measures of cognitive conflict (Simon Task) and affective activation (Affective circumplex task) fMRI a. Simon Task: i. We expect reduced frontal cortex activation in depressed subjects, and ii. normalization of frontal cortex activation following treatment. b. Affective Circumplex Task: i. Reduced amygdala and hippocampal activation in depressed subjects, ii. normalization of activation in these areas following treatment. |
10 weeks | No |
Secondary | Magnetic Resonance Spectroscopic Imaging (MRSI) | Magnetic resonance spectroscopic imaging. We expect to find decreased levels of N-Acetyl-Aspartate (NAA) in frontal cortex (dorsal prefrontal, subgenual prefrontal cortex, and orbitofrontal cortex gray matter), as well as in hippocampus, amygdala, caudate, and putamen. | 10 weeks | No |
Secondary | Cornell Dysthymia Rating Scale (CDRS) | CDRS is a 20-item clinician-rated inventory for chronic depressive symptoms. Each item was characterized by an explanatory or illustrative description and rated from 0 (symptom absent) to 4 (severe symptoms). Scores from 0 to 82 with higher score indicating worse depression |
Baseline | No |
Secondary | Beck Depression Inventory (BDI) | Beck Depression Inventory (BDI)is a 21-question multiple-choice self-report inventory, one of the most widely used instruments for measuring the severity of depression. When the test is scored, a value of 0 to 3 is assigned for each answer and then the total score is compared to a key to determine the depression's severity. The standard cut-offs are as follows:[7] 0-9: indicates minimal depression 10-18: indicates mild depression 19-29: indicates moderate depression 30-63: indicates severe depression. Higher total scores indicate more severe depressive symptoms. |
Baseline | No |
Secondary | Global Assessment of Functioning Scale (GAF) | A commonly used rating scale for global social function. Range from 0 to 100; higher score=better functioning. 91 - 100 No symptoms. 81 - 90 Absent or minimal symptoms 71 - 80 no more than slight impairment in social, occupational, or school functioning (e.g., temporarily falling behind in schoolwork). 61 - 70 Some mild symptoms 51 - 60 Moderate symptoms 41 - 50 Serious symptoms 31 - 40 Some impairment in reality testing or communication 21 - 30 Behavior is considerably influenced by delusions or hallucinations or serious impairment, in communication or judgment 11 - 20 Some danger of hurting self or others 1 - 10 Persistent danger of severely hurting self or others or persistent inability to maintain minimal personal hygiene or serious suicidal act with clear expectation of death. 0 Inadequate information |
Baseline | No |
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