Duloxetine for Chronic Depression: a Double-blind Study
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| ClinicalTrials.gov Identifier: NCT00360724 |
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Recruitment Status :
Completed
First Posted : August 7, 2006
Results First Posted : November 3, 2015
Last Update Posted : August 21, 2017
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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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Dysthymic Disorder Depressive Disorder NOS | Drug: Duloxetine (Cymbalta) | Phase 4 |
This is a 22-week study of the tolerability, dosing, and efficacy of duloxetine in chronically depressed outpatients. Participants can have Dysthymic Disorder (Dysthymia), or Depression, Not Otherwise Specified (Depression NOS).
The first 10 weeks (Acute Phase) are double blind, placebo-controlled, and the second 12 weeks (Continuation Phase) is open-label and all subjects will receive active medication.
Tests of cytokine functioning will be performed and analyzed for treatment and placebo effects.
In addition, a subset of patients will be enrolled into an Magnetic Resonance Imaging (MRI) sub-study, in which a variety of brain imaging techniques (including anatomical MRI, functional MRI (fMRI), MR Spectroscopy, and Diffusion Tensor Imaging) will be performed at baseline and week 10. Duloxetine responders will have a third MRI performed at week 22.
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 65 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
| Primary Purpose: | Treatment |
| Official Title: | Duloxetine for Chronic Depression: a Double-blind Study |
| Study Start Date : | August 2006 |
| Actual Primary Completion Date : | December 2011 |
| Actual Study Completion Date : | December 2013 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: duloxetine (cymbalta)
Duloxetine medication: a medication currently marketed in the USA that is reported to have pharmacological effects including reuptake blockage for serotonin and norepinephrine
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Drug: Duloxetine (Cymbalta)
duloxetine medication up to dose of 120 mg/day
Other Names:
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Placebo Comparator: Placebo treatment
placebo treatment: treatment with placebo capsules that match active medication capsules
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Drug: Duloxetine (Cymbalta)
duloxetine medication up to dose of 120 mg/day
Other Names:
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- Hamilton Depression Rating Scale (HDRS) - 24 Total Score [ Time Frame: Week 10 ]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
- Hamilton Depression Rating Scale (HDRS) - 24 Total Score [ Time Frame: Baseline ]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
- Cornell Dysthymia Rating Scale (CDRS) [ Time Frame: Week 10 ]
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
- Global Assessment of Functioning Scale (GAF) [ Time Frame: Week 10 ]
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
- Beck Depression Inventory (BDI) [ Time Frame: Week 10 ]
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.
- Clinical Global Impressions Improvement(CGI-I) [ Time Frame: 10 weeks ]
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
- Cornell Dysthymia Rating Scale (CDRS) [ Time Frame: Baseline ]
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
- Beck Depression Inventory (BDI) [ Time Frame: Baseline ]
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.
- Global Assessment of Functioning Scale (GAF) [ Time Frame: Baseline ]
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
- Resting-state Functional Connectivity Magnetic Resonance Imaging(fMRI) [ Time Frame: Baseline ]To use resting-state fMRI to study the effects of antidepressant therapy on default mode network (DMN) connectivity density.
- Resting-state Functional Connectivity Magnetic Resonance Imaging(fMRI) [ Time Frame: Follow up ]To use resting-state fMRI to study the effects of antidepressant therapy on default mode network (DMN) connectivity density.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 20 Years to 75 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00360724
| United States, New York | |
| New York State Psychiatric Institute | |
| New York, New York, United States, 10032 | |
| Principal Investigator: | David J. Hellerstein, MD | New York State Psychiatric Institute |
Publications of Results:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | New York State Psychiatric Institute |
| ClinicalTrials.gov Identifier: | NCT00360724 |
| Other Study ID Numbers: |
# 4967/6363R |
| First Posted: | August 7, 2006 Key Record Dates |
| Results First Posted: | November 3, 2015 |
| Last Update Posted: | August 21, 2017 |
| Last Verified: | July 2017 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
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dysthymia dysthymic disorder chronic depression chronic low-grade depression atypical depression minor depression |
depression NOS depression depressive disorder mood disorder unipolar depression low-grade depression |
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Disease Depression Depressive Disorder Dysthymic Disorder Pathologic Processes Behavioral Symptoms Mood Disorders Mental Disorders Duloxetine Hydrochloride Serotonin and Noradrenaline Reuptake Inhibitors Neurotransmitter Uptake Inhibitors |
Membrane Transport Modulators Molecular Mechanisms of Pharmacological Action Neurotransmitter Agents Physiological Effects of Drugs Analgesics Sensory System Agents Peripheral Nervous System Agents Antidepressive Agents Psychotropic Drugs Dopamine Agents |