Dysthymic DisorderPhase 4NCT00360724

Duloxetine for Chronic Depression: a Double-blind Study

A Phase 4 study testing Duloxetine (Cymbalta) in people with Dysthymic Disorder and Depressive Disorder NOS, run by New York State Psychiatric Institute at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 20 to 75 years
Conditions the study is for: Dysthymic Disorder, Depressive Disorder NOS
What is being tested?: Duloxetine (Cymbalta)
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 65 participants
Where: 1 siteUnited States
Study dates: Aug 2006to Dec 2013
Phase: Phase 4
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 20 to 75 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United States1 site

New York State Psychiatric Institute
New York, New York, 10032

Other trials in United States

About this 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.

Read the detailed description

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.

Conditions: Dysthymic Disorder, Depressive Disorder NOS
Being tested: Duloxetine (Cymbalta)
Keywords: 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
Medical subject headings: Dysthymic Disorder, Depression, Depressive Disorder, Mood Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Duloxetine (Cymbalta)Drug
Also called duloxetine, Cymbalta
duloxetine medication up to dose of 120 mg/day

Study groups in NCT00360724
Study group	Role	What they receive
duloxetine (cymbalta)	Experimental	Duloxetine medication: a medication currently marketed in the USA that is reported to have pharmacological effects including reuptake blockage for serotonin and norepinephrine Receives: Drug: Duloxetine (Cymbalta)
Placebo treatment	Placebo comparator	placebo treatment: treatment with placebo capsules that match active medication capsules Receives: Drug: Duloxetine (Cymbalta)

What is being measured

The primary outcome is the main question the study is designed to answer.

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
Measured: 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
Measured: Baseline

Secondary outcomes (7)

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
Measured: 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
Measured: 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.
Measured: 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
Measured: 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
Measured: 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.
Measured: 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
Measured: Baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Aug 2006Dec 2013

First posted7 Aug 2006 (estimated)
Study startAug 2006
Primary completionDec 2011
Study completionDec 2013

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (5)Papers the sponsor has linked to this study.
Other trials for Dysthymic DisorderStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 4
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 65 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00360724
Sponsor's protocol ID: # 4967/6363R
Status last verified: Jul 2017
First submitted: 3 Aug 2006
Last updated: 21 Aug 2017
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: No

Publications

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):984-91. doi: 10.4088/JCP.11m07230.
PubMed 22901348
Bansal R, Hellerstein DJ, Sawardekar S, Chen Y, Peterson BS. Effects of antidepressant medications on brain tissue microstructure in persistent depressive disorder across two randomized controlled trials. Neuroimage Clin. 2026;50:104013. doi: 10.1016/j.nicl.2026.104013. Epub 2026 May 27.
PubMed 42214294
Yang J, Hellerstein DJ, Chen Y, McGrath PJ, Stewart JW, Peterson BS, Wang Z. Serotonin-norepinephrine reuptake inhibitor antidepressant effects on regional connectivity of the thalamus in persistent depressive disorder: evidence from two randomized, double-blind, placebo-controlled clinical trials. Brain Commun. 2022 Apr 15;4(3):fcac100. doi: 10.1093/braincomms/fcac100. eCollection 2022.
PubMed 35592490
Bansal R, Hellerstein DJ, Sawardekar S, O'Neill J, Peterson BS. Effects of the antidepressant medication duloxetine on brain metabolites in persistent depressive disorder: A randomized, controlled trial. PLoS One. 2019 Jul 19;14(7):e0219679. doi: 10.1371/journal.pone.0219679. eCollection 2019.
PubMed 31323045
Hellerstein DJ, Hunnicutt-Ferguson K, Stewart JW, McGrath PJ, Keller S, Peterson BS, Chen Y. Do social functioning and symptoms improve with continuation antidepressant treatment of persistent depressive disorder? An observational study. J Affect Disord. 2017 Mar 1;210:258-264. doi: 10.1016/j.jad.2016.12.026. Epub 2016 Dec 20.
PubMed 28064115

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Dysthymic Disorder trials

Study at a glance

From the registry record, last updated by the sponsor on 21 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Duloxetine for Chronic Depression: a Double-blind Study
ClinicalTrials.gov ID: NCT00360724
Acronym / sponsor ID: # 4967/6363R
Conditions: Dysthymic Disorder, Depressive Disorder NOS
Keywords: dysthymia, dysthymic disorder, chronic depression, chronic low-grade depression, atypical depression, minor depression, depression NOS, depression
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 65 participants (actual)
Lead sponsor: New York State Psychiatric InstituteUniversity, hospital or other
Collaborators: Eli Lilly and Company
Study start: Aug 2006
Primary completion: Dec 2011 (actual)
Study completion: Dec 2013 (actual)
First posted: 7 Aug 2006 (estimated)
Results: Posted 3 Nov 2015

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Eligible subjects may also receive MRI scans, to help the investigators understand how antidepressants work in treating depression.

Detailed description

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.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
duloxetine (cymbalta)	Experimental	Drug: 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
Placebo treatment	Placebo comparator	Drug: Duloxetine (Cymbalta)placebo treatment: treatment with placebo capsules that match active medication capsules

Who may qualify

Ages: 20 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

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

Key exclusion criteria (5 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Duloxetine (Cymbalta)Also: duloxetine, Cymbaltaduloxetine medication up to dose of 120 mg/day	Drug	Placebo treatment, duloxetine (cymbalta)

Primary outcome

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

7 secondary outcomes

Cornell Dysthymia Rating Scale (CDRS)
Time frame: Week 10
Global Assessment of Functioning Scale (GAF)
Time frame: Week 10
Beck Depression Inventory (BDI)
Time frame: Week 10
Clinical Global Impressions Improvement(CGI-I)
Time frame: 10 weeks
Cornell Dysthymia Rating Scale (CDRS)
Time frame: Baseline
Beck Depression Inventory (BDI)
Time frame: Baseline
Global Assessment of Functioning Scale (GAF)
Time frame: Baseline

Results and safety

Results posted to the registry on 3 Nov 2015, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Duloxetine (Cymbalta)	33	29
Placebo Treatment	32	28

Primary outcome: Hamilton Depression Rating Scale (HDRS) - 24 Total Score

Time frame: Week 10. Mean (Standard Deviation). Unit: Scores on a scale

Measure	Duloxetine (Cymbalta) n = 29	Placebo Treatment n = 28
Value	5 (3.6)	10 (5.5)

Duloxetine (Cymbalta) vs Placebo Treatment: F statistics: 9.43, p = .003, Repeated Measures ANOVA

Population analysed: Patients for whom post-baseline data was available and scored 2 or less on the suicide item either at baseline or during the course of treatment.

Primary outcome: Hamilton Depression Rating Scale (HDRS) - 24 Total Score

Time frame: Baseline. Mean (Standard Deviation). Unit: Scores on a scale

Measure	Duloxetine (Cymbalta) n = 29	Placebo Treatment n = 28
Value	14.1 (3.8)	14.9 (3.5)

Population analysed: Patients for whom post-baseline data was available and scored 2 or less on the suicide item either at baseline or during the course of treatment.

7 secondary outcomes are reported in the full results.

Adverse events

Time frame: patients were treated in study for 22 weeks, including 10 weeks double blind medication vs placebo and 12 weeks open label treatment.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Duloxetine (Cymbalta)	0 of 33 (0%)	27 of 29 (93.1%)	Not reported
Placebo Treatment	0 of 32 (0%)	22 of 28 (78.6%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 22901348Hellerstein 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):984-91. doi: 10.4088/JCP.11m07230.
Derived from this study: PubMed 42214294Bansal R, Hellerstein DJ, Sawardekar S, Chen Y, Peterson BS. Effects of antidepressant medications on brain tissue microstructure in persistent depressive disorder across two randomized controlled trials. Neuroimage Clin. 2026;50:104013. doi: 10.1016/j.nicl.2026.104013. Epub 2026 May 27.
Derived from this study: PubMed 35592490Yang J, Hellerstein DJ, Chen Y, McGrath PJ, Stewart JW, Peterson BS, Wang Z. Serotonin-norepinephrine reuptake inhibitor antidepressant effects on regional connectivity of the thalamus in persistent depressive disorder: evidence from two randomized, double-blind, placebo-controlled clinical trials. Brain Commun. 2022 Apr 15;4(3):fcac100. doi: 10.1093/braincomms/fcac100. eCollection 2022.
Derived from this study: PubMed 31323045Bansal R, Hellerstein DJ, Sawardekar S, O'Neill J, Peterson BS. Effects of the antidepressant medication duloxetine on brain metabolites in persistent depressive disorder: A randomized, controlled trial. PLoS One. 2019 Jul 19;14(7):e0219679. doi: 10.1371/journal.pone.0219679. eCollection 2019.
Derived from this study: PubMed 28064115Hellerstein DJ, Hunnicutt-Ferguson K, Stewart JW, McGrath PJ, Keller S, Peterson BS, Chen Y. Do social functioning and symptoms improve with continuation antidepressant treatment of persistent depressive disorder? An observational study. J Affect Disord. 2017 Mar 1;210:258-264. doi: 10.1016/j.jad.2016.12.026. Epub 2016 Dec 20.
Mood Disorders Research Program websiteLink provided by the sponsor.
Columbia University Department of Psychiatry websiteLink provided by the sponsor.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

David J. Hellerstein, MD principal investigator

New York State Psychiatric Institute

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Duloxetine (Cymbalta) in people with Dysthymic Disorder and Depressive Disorder NOS, run by New York State Psychiatric Institute at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 21 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 3 Nov 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Hamilton Depression Rating Scale (HDRS) - 24 Total Score (time frame: Week 10). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00360724, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Aug 2017.