A Phase 4 interventional study of Duloxetine (Cymbalta) in Dysthymic Disorder and Depressive Disorder NOS, sponsored by New York State Psychiatric Institute. Completed at 1 site in United States. Open to participants aged 20 Years to 75 Years. Per ClinicalTrials.gov, last updated 2017-08-21.
Sponsored by New York State Psychiatric Institute · Phase 4, Interventional, and Treatment
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.
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.
8,057 studies on the registry are indexed under Depression; 1,641 are open to participants now.
This study's enrollment of 65 is below the median of 84 across 6,720 interventional studies indexed under Depression.
Browse Depression studies →New York State Psychiatric Institute is the lead sponsor of 425 studies on the registry; 26 are open to participants now.
Of its 50 completed or terminated interventional studies of FDA-regulated products, 45 (90%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Duloxetine medication: a medication currently marketed in the USA that is reported to have pharmacological effects including reuptake blockage for serotonin and norepinephrine
Drug: Duloxetine (Cymbalta)
placebo treatment: treatment with placebo capsules that match active medication capsules
Drug: Duloxetine (Cymbalta)
duloxetine medication up to dose of 120 mg/day
Also known as: duloxetine, Cymbalta
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
Time frame: Week 10
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
Time frame: Baseline
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
Time frame: Week 10
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
Time frame: Week 10
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.
Time frame: Week 10
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 1. = Very much improved 2. = Much improved 3. = Minimally improved 4. = No change 5. = Minimally worse 6. = Much worse 7. = Very much worse Higher score=greatest worsening
Time frame: 10 weeks
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
Time frame: Baseline
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.
Time frame: Baseline
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
Time frame: Baseline
Resting-state Functional Connectivity Magnetic Resonance Imaging(fMRI)
To use resting-state fMRI to study the effects of antidepressant therapy on default mode network (DMN) connectivity density.
Time frame: Baseline
Resting-state Functional Connectivity Magnetic Resonance Imaging(fMRI)
To use resting-state fMRI to study the effects of antidepressant therapy on default mode network (DMN) connectivity density.
Time frame: Follow up
Subjects were recruited by advertisements, website postings, and from the hospital's telephone referral service. Conducted between August 2006 and December 2011. Potential participants provided informed consent for study participation. A physical examination was performed and blood and urine samples were collected, including urine toxicology.
| Milestone | Duloxetine (Cymbalta) | Placebo Treatment |
|---|---|---|
| Started | 33 | 32 |
| Completed | 29 | 28 |
| Not completed | 4 | 4 |
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
| Scores on a scale | Duloxetine (Cymbalta) | Placebo Treatment |
|---|---|---|
| Hamilton Depression Rating Scale (HDRS) - 24 Total Score | 5 ± 3.6 | 10 ± 5.5 |
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
| Scores on a scale | Duloxetine (Cymbalta) | Placebo Treatment |
|---|---|---|
| Hamilton Depression Rating Scale (HDRS) - 24 Total Score | 14.1 ± 3.8 | 14.9 ± 3.5 |
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
| scores on a scale | Duloxetine (Cymbalta) | Placebo Treatment |
|---|---|---|
| Cornell Dysthymia Rating Scale (CDRS) | 19.1 ± 9.5 | 28.5 ± 14.6 |
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
| points on rating scale | Duloxetine (Cymbalta) | Placebo Treatment |
|---|---|---|
| Global Assessment of Functioning Scale (GAF) | 69.9 ± 20.9 | 65.7 ± 14 |
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.
| Scores on a scale | Duloxetine (Cymbalta) | Placebo Treatment |
|---|---|---|
| Beck Depression Inventory (BDI) | 8.5 ± 7 | 10.1 ± 6.2 |
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 1. = Very much improved 2. = Much improved 3. = Minimally improved 4. = No change 5. = Minimally worse 6. = Much worse 7. = Very much worse Higher score=greatest worsening
| Scores on a scale | Duloxetine (Cymbalta) | Placebo Treatment |
|---|---|---|
| Clinical Global Impressions Improvement(CGI-I) | 2.4 ± .8 | 3 ± 1.1 |
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
| Scores on a scale | Duloxetine (Cymbalta) | Placebo Treatment |
|---|---|---|
| Cornell Dysthymia Rating Scale (CDRS) | 36.9 ± 8.0 | 37.4 ± 8.0 |
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.
| Scores on a scale | Duloxetine (Cymbalta) | Placebo Treatment |
|---|---|---|
| Beck Depression Inventory (BDI) | 12.7 ± 5.8 | 15.5 ± 5.5 |
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
| points on rating scale | Duloxetine (Cymbalta) | Placebo Treatment |
|---|---|---|
| Global Assessment of Functioning Scale (GAF) | 62.6 ± 5.8 | 58.3 ± 7.0 |
To use resting-state fMRI to study the effects of antidepressant therapy on default mode network (DMN) connectivity density.
| percentage of connecting nods | Duloxetine (Cymbalta) | Placebo Treatment |
|---|---|---|
| Resting-state Functional Connectivity Magnetic Resonance Imaging(fMRI) | 0.21 ± 0.08 | 0.24 ± 0.06 |
To use resting-state fMRI to study the effects of antidepressant therapy on default mode network (DMN) connectivity density.
| percentage of connecting nods | Duloxetine (Cymbalta) | Placebo Treatment |
|---|---|---|
| Resting-state Functional Connectivity Magnetic Resonance Imaging(fMRI) | 0.16 ± 0.06 | 0.19 ± 0.08 |
Collected over patients were treated in study for 22 weeks, including 10 weeks double blind medication vs placebo and 12 weeks open label treatment.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Duloxetine (Cymbalta) | — | 0/33 (0%) | 27/29 (93.1%) |
| Placebo Treatment | — | 0/32 (0%) | 22/28 (78.6%) |
| Event | Duloxetine (Cymbalta) | Placebo Treatment |
|---|---|---|
| GI upsetGastrointestinal disorders | 7/29 | 9/28 |
| FatigueGeneral disorders | 9/29 | 8/28 |
| Decreased AppetiteGeneral disorders | 8/29 | 4/28 |
| Vivid DreamGeneral disorders | 7/29 | 1/28 |
| NauseaGeneral disorders | 6/29 | 5/28 |
| Decreased SleepGeneral disorders | 6/29 | 4/28 |
| DizzinessGeneral disorders | 2/29 | 4/28 |
| Age, Categorical(Participants) | Duloxetine (Cymbalta) | Placebo Treatment | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 32 | 32 | 64 |
| >=65 years | 1 | 0 | 1 |
| Age, Continuous(years) | Duloxetine (Cymbalta) | Placebo Treatment | Total |
|---|---|---|---|
| Mean | 41 ± 11.7 | 42.1 ± 11.4 | 41.6 ± 11.2 |
| Sex: Female, Male(Participants) | Duloxetine (Cymbalta) | Placebo Treatment | Total |
|---|---|---|---|
| Female | 18 | 10 | 28 |
| Male | 15 | 22 | 37 |
| Region of Enrollment(participants) | Duloxetine (Cymbalta) | Placebo Treatment | Total |
|---|---|---|---|
| United States | 33 | 32 | 65 |
Plan to share: No
This study is completed, as verified in Jul 2017. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
New York State Psychiatric Institute