NCT00427128

Brief Summary

This study randomized two stratifications of acute phase MDD SSRI responders, categorized as having either "true drug" response or "placebo response" pattern, to continuation with SSRI vs placebo in a double-blind trial to determine if stratification category predicted continuation outcome.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
627

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Nov 1995

Longer than P75 for phase_4

Geographic Reach
1 country

2 active sites

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

November 1, 1995

Completed
7.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2003

Completed
3.9 years until next milestone

First Submitted

Initial submission to the registry

January 24, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 26, 2007

Completed
Last Updated

December 15, 2011

Status Verified

December 1, 2011

First QC Date

January 24, 2007

Last Update Submit

December 14, 2011

Conditions

Major Depression

Keywords

Major Depression"true drug" response"placebo response" patterncontinuation treatment outcomes

Outcome Measures

Primary Outcomes (3)

  • MDD section of Mood Disorders Module of Structured Clinical Interview for DSM-IV (SCID)

    up to 9 mos.

  • Ham-D

    up to 9 mos.

  • CGI

    up to 9 mos.

Interventions

fluoxetineDRUG

10mg/day increased over 12 weeks to 20-80 mg/day; 20-80 mg/day maintained from week 13-36.

Also known as: Prozac
placeboDRUG

Week 13-36.

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • men and women ages 18-65
  • meets criteria for DSM IV Major Depression
  • signs informed consent and able to comply with study

You may not qualify if:

  • pregnant women and women of child-bearing potential who are not using a medically accepted means of contraception.
  • women taking oral contraceptives, the initiation of which was temporally associated with the onset of depression; women who are breast-feeding.
  • Patients with serious suicidal risk, including any patient who became suicidal with previous discontinuation of an antidepressant.
  • Patients with a history of seizure disorder.
  • Patients with unstable physical disorders (cardiovascular, hepatic, renal, respiratory, endocrine, neurologic, or hematologic) or any physical disorder judged to significantly affect CNS function.
  • Patients meeting criteria for the following DSM-IV diagnoses: organic mental disorders; substance use disorders, including alcohol, active within the last 6 months; schizophrenia; delusional disorder; psychotic disorders; bipolar disorder; antisocial personality disorder; or presence of psychotic features
  • Patients with a history of non-response to an adequate trial of a selective serotonin reuptake inhibitor in a past or current depressive episode, defined as a four-week trial of a minimum of 40mg/day of fluoxetine or paroxetine, or 100mg/day of sertraline.
  • Clinical or laboratory evidence of hypothyroidism without adequate stable replacement (eg, low total T4 or elevated TSH by a high sensitivity method).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

New York State Psychiatric Institute

New York, New York, 10032, United States

Location

Related Publications (3)

  • McGrath PJ, Stewart JW, Quitkin FM, Chen Y, Alpert JE, Nierenberg AA, Fava M, Cheng J, Petkova E. Predictors of relapse in a prospective study of fluoxetine treatment of major depression. Am J Psychiatry. 2006 Sep;163(9):1542-8. doi: 10.1176/ajp.2006.163.9.1542.

    PMID: 16946178RESULT

  • Posternak MA, Baer L, Nierenberg AA, Fava M. Response rates to fluoxetine in subjects who initially show no improvement. J Clin Psychiatry. 2011 Jul;72(7):949-54. doi: 10.4088/JCP.10m06098. Epub 2011 May 31.

    PMID: 21672502DERIVED

  • Yang H, Sinicropi-Yao L, Chuzi S, Youn SJ, Clain A, Baer L, Chen Y, McGrath PJ, Fava M, Papakostas GI. Residual sleep disturbance and risk of relapse during the continuation/maintenance phase treatment of major depressive disorder with the selective serotonin reuptake inhibitor fluoxetine. Ann Gen Psychiatry. 2010 Feb 26;9:10. doi: 10.1186/1744-859X-9-10.

    PMID: 20187924DERIVED

Related Links

MeSH Terms

Conditions

Depressive Disorder, Major

Interventions

Fluoxetine

Condition Hierarchy (Ancestors)

Depressive DisorderMood DisordersMental Disorders

Intervention Hierarchy (Ancestors)

PropylaminesAminesOrganic Chemicals

Study Officials

  • Patrick J McGrath, MD

    New York State Psychiatric Institute

    PRINCIPAL INVESTIGATOR

  • Maurizio Fava, MD

    Massachussets General Hospital

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

January 24, 2007

First Posted

January 26, 2007

Study Start

November 1, 1995

Study Completion

March 1, 2003

Last Updated

December 15, 2011

Record last verified: 2011-12

Locations

US(2)