Desvenlafaxine vs. Placebo Treatment of Chronic Depression

NCT01537068 | Completed Phase 4 Results

• 1 other identifier: #6457 Pfizer-WS1895577
• Study Type: interventional
• Target: 59
• Locations: 1 country
• Sites: 2

Brief Summary

The investigators are studying a new antidepressant medicine, desvenlafaxine, for the treatment of people with chronic depression. Desvenlafaxine (trade name Pristiq) has been approved by the FDA for the treatment of major depression. The investigators are testing whether this medicine is also effective for adults with a type of chronic depression that is less severe than major depression. This condition is also known as dysthymic disorder or dysthymia. Chronic depression, lasting two or more years, often causes significant suffering and impairment. In addition, the investigators are using MRI imaging, which uses magnetic signals to make pictures of the brain's structure and also of its functioning. The purpose of MRI imaging in this study is to see whether chronic depression is associated with differences in brain structure or functioning, and whether such differences change after medication or placebo treatment. To test this MRI scans are done at the start of the study and after 12 weeks of medication or placebo treatment. Getting MRI imaging will be an option for participants in this study but is not required. This study involves a 6 to 12 week double-blind period during which half of the participants will take the new medication and half will take a placebo (an inactive look-alike pill). After the double blind phase, all subjects can be treated for 12 weeks with an FDA-approved antidepressant medication. Assessments (of depressive symptoms, social functioning, and personality) will be done by study staff and by patients before the study starts, at each study visit for the first 12 weeks, and again after 24 weeks in the study.

Conditions

Dysthymic Disorder; Dysthymia; Chronic Depressive Disorder

Keywords

Dysthymic disorder; Dysthymia; Chronic non-major depression; Non-major chronic depression; Chronic depressive disorder; Antidepressant treatment

Outcome Measures

Primary Outcomes (2)

• Hamilton Rating Scale for Depression (HDRS24)

  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

• Hamilton Rating Scale for Depression (HDRS24)

  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 12

Secondary Outcomes (1)

• Response Rate

  12 weeks

Study Arms (2)

Desvenlafaxine

EXPERIMENTAL

Serotonin-norepinephrine reuptake inhibitors (SNRIs) antidepressant drug

Drug: Desvenlafaxine

Placebo

PLACEBO COMPARATOR

Placebo treatment

Drug: Placebo

Interventions

Desvenlafaxine DRUG

Desvenlafaxine oral dose ranging from 50 to 100 mg/day

Also known as: Pristiq

Desvenlafaxine

Placebo DRUG

Matching placebo pills

Also known as: Inactive comparator

Placebo

Eligibility Criteria

• Age: 20 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male and female outpatients 20 to 65 years of age, inclusive
• Principal DSM-5 diagnosis of unipolar non-major Chronic Depressive Disorder (including Major Depression in partial remission, Major Depression, residual, Dysthymic Disorder, or Depressive Disorder NOS)
• Minimum of 2 years duration of the current episode of depressive disorder.
• Score of 12 or higher on the Hamilton Depression Scale (24 items) at baseline

You may not qualify if:

• Full remission of depression in past 24 months
• Current major depression diagnosis, psychotic illness
• Current risk of suicide
• Drug or alcohol abuse/dependence in past 6 months
• Active medical illness
• Prior nonresponse to desvenlafaxine
• Medical illness contraindicating use of desvenlafaxine
• Current or planned pregnancy during study period

Sponsors & Collaborators

• New York State Psychiatric Institute: lead
• Pfizer: collaborator

Study Sites (2)

New York State Psychiatric Institute/3 Columbus Circle Midtown

New York, New York, 10019, United States

Location

Depression Evaluation Service (DES), New York State Psychiatric Institute, Columbia University Department of Psychiatry

New York, New York, 10032, United States

Location

Related Publications (5)

• DeMartinis NA, Yeung PP, Entsuah R, Manley AL. A double-blind, placebo-controlled study of the efficacy and safety of desvenlafaxine succinate in the treatment of major depressive disorder. J Clin Psychiatry. 2007 May;68(5):677-88. doi: 10.4088/jcp.v68n0504.

  PMID: 17503976 BACKGROUND

• Levkovitz Y, Tedeschini E, Papakostas GI. Efficacy of antidepressants for dysthymia: a meta-analysis of placebo-controlled randomized trials. J Clin Psychiatry. 2011 Apr;72(4):509-14. doi: 10.4088/JCP.09m05949blu.

  PMID: 21527126 BACKGROUND

• Bansal R, Hellerstein DJ, Sawardekar S, Chen Y, Peterson BS. A randomized controlled trial of desvenlafaxine-induced structural brain changes in the treatment of persistent depressive disorder. Psychiatry Res Neuroimaging. 2023 Jun;331:111634. doi: 10.1016/j.pscychresns.2023.111634. Epub 2023 Mar 24.

  PMID: 36996664 DERIVED

• 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: 35592490 DERIVED

• Hellerstein DJ, Stewart JW, Chen Y, Arunagiri V, Peterson BS, McGrath PJ. Desvenlafaxine vs. placebo in the treatment of persistent depressive disorder. J Affect Disord. 2019 Feb 15;245:403-411. doi: 10.1016/j.jad.2018.11.065. Epub 2018 Nov 5.

  PMID: 30423468 DERIVED

Related Links

• Depression Evaluation Service, NY State Psychiatric Institute website
• Columbia Psychiatry website, clinical trials

MeSH Terms

Conditions

Dysthymic Disorder

Interventions

Desvenlafaxine Succinate

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Cyclohexanols; Hexanols; Fatty Alcohols; Alcohols; Organic Chemicals; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Lipids

Results Point of Contact

• Title: David Hellerstein MD
• Organization: NYSPI

desdesk@nyspi.columbia.edu

646-774-8000

Study Officials

• David J Hellerstein, MD

  New York State Psychiatric Institute, Columbia University Department of Psychiatry

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

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: February 16, 2012
• First Posted: February 22, 2012
• Study Start: February 1, 2012
• Primary Completion: August 1, 2016
• Study Completion: December 1, 2016
• Last Updated: September 11, 2017
• Results First Posted: September 11, 2017

Record last verified: 2017-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)