Skip to main content
OpenTrials
Completed

NCT Number: NCT00360724

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Dysthymic Disorder Behavior Behavioral Symptoms Depression Depressive Disorder Depressive Disorder NOS Mental Disorders Mood Disorders

Age range

20 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

New York State Psychiatric Institute

New York, 10032, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Duloxetine (Cymbalta)

Drug

duloxetine medication up to dose of 120 mg/day

Other names: duloxetine, Cymbalta

Primary outcomes

  1. 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

  2. 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

Secondary outcomes

  1. 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

  2. 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

  3. 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.

  4. 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

  5. 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

  6. 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.

  7. 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

Other outcomes

  1. 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.

  2. 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.

Sponsors and collaborators

Lead sponsor

New York State Psychiatric Institute

Other

Collaborators

  • Eli Lilly and Company

Registry information

Important dates

Study start
2006
Primary completion
2011
Study completion
2013
First posted
Aug 7, 2006
Registry last updated
Aug 21, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.