NCT00360724

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
65

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Aug 2006

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2006

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

August 3, 2006

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 7, 2006

Completed
5.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2011

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2013

Completed
1.9 years until next milestone

Results Posted

Study results publicly available

November 3, 2015

Completed
Last Updated

August 21, 2017

Status Verified

July 1, 2017

Enrollment Period

5.3 years

First QC Date

August 3, 2006

Results QC Date

October 1, 2013

Last Update Submit

July 20, 2017

Conditions

Dysthymic DisorderDepressive Disorder NOS

Keywords

dysthymiadysthymic disorderchronic depressionchronic low-grade depressionatypical depressionminor depressiondepression NOSdepressiondepressive disordermood disorderunipolar depressionlow-grade depression

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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

Secondary Outcomes (7)

  • Cornell Dysthymia Rating Scale (CDRS)

    Week 10

  • Global Assessment of Functioning Scale (GAF)

    Week 10

  • Beck Depression Inventory (BDI)

    Week 10

  • Clinical Global Impressions Improvement(CGI-I)

    10 weeks

  • Cornell Dysthymia Rating Scale (CDRS)

    Baseline

  • +2 more secondary outcomes

Other Outcomes (2)

  • Resting-state Functional Connectivity Magnetic Resonance Imaging(fMRI)

    Baseline

  • Resting-state Functional Connectivity Magnetic Resonance Imaging(fMRI)

    Follow up

Study Arms (2)

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

Drug: Duloxetine (Cymbalta)

Placebo treatment

PLACEBO COMPARATOR

placebo treatment: treatment with placebo capsules that match active medication capsules

Drug: Duloxetine (Cymbalta)

Interventions

Duloxetine (Cymbalta)DRUG

duloxetine medication up to dose of 120 mg/day

Also known as: duloxetine, Cymbalta
Placebo treatmentduloxetine (cymbalta)

Eligibility Criteria

Age20 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

New York State Psychiatric Institute

New York, New York, 10032, United States

Location

Related Publications (4)

  • 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.

    PMID: 22901348RESULT

  • 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.

    PMID: 35592490DERIVED

  • 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.

    PMID: 31323045DERIVED

  • 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.

    PMID: 28064115DERIVED

Related Links

MeSH Terms

Conditions

Dysthymic DisorderDepressionDepressive DisorderMood Disorders

Interventions

Duloxetine Hydrochloride

Condition Hierarchy (Ancestors)

Mental DisordersBehavioral SymptomsBehavior

Intervention Hierarchy (Ancestors)

ThiophenesSulfur CompoundsOrganic ChemicalsHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Results Point of Contact

Title
David Hellerstein MD
Organization
NY State Psychiatric Institute
hellers@nyspi.columbia.edu
6467748000

Study Officials

  • David J. Hellerstein, MD

    New York State Psychiatric Institute

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
LTE60
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 3, 2006

First Posted

August 7, 2006

Study Start

August 1, 2006

Primary Completion

December 1, 2011

Study Completion

December 1, 2013

Last Updated

August 21, 2017

Results First Posted

November 3, 2015

Record last verified: 2017-07

Data Sharing

IPD Sharing
Will not share

Locations

US(1)