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Treatment of Depression in Adults

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00073697
Recruitment Status : Completed
First Posted : December 3, 2003
Last Update Posted : January 11, 2012
Sponsor:
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by:
University of Pittsburgh

Tracking Information
First Submitted Date  ICMJE December 2, 2003
First Posted Date  ICMJE December 3, 2003
Last Update Posted Date January 11, 2012
Study Start Date  ICMJE May 2003
Actual Primary Completion Date October 2007   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 10, 2007)
  • Hamilton Rating Scale for Depression score [ Time Frame: Measured at Months 8 and 14 ]
  • Treatment-relevant phenotypes of depression [ Time Frame: Measured at Months 8 and 14 ]
Original Primary Outcome Measures  ICMJE Not Provided
Change History Complete list of historical versions of study NCT00073697 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Treatment of Depression in Adults
Official Title  ICMJE Depression: The Search for Treatment-Relevant Phenotypes
Brief Summary This study will determine how certain features of depressed individuals affect their responses to depression treatment.
Detailed Description

Major depression is a serious condition that can have devastating functional consequences. Although numerous depression studies have been conducted, understanding of how best to achieve long-term recovery remains limited. This study will assess the mood, personality, pharamcokinetic and genetic characteristics of depressed participants to determine the effects of these features on treatment response.

This study will be conducted at two international treatment sites, including the University of Pittsburgh and the University of Pisa, Italy. Participants will be randomly assigned to receive either interpersonal psychotherapy (IPT) or escitalopram pharmacotherapy for a minimum of 32 weeks or approximately 8 months. Participants whose symptoms become stabilized will continue the initial treatment for another 6 months; those who do not will have the second treatment added to their regimen until remission occurs. Clinical evaluations and questionnaires will be used to assess participants.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Depression
Intervention  ICMJE
  • Drug: Escitalopram
    Participants will receive escitalopram for a minimum of 32 weeks or approximately 8 months. Participants whose symptoms become stabilized will continue the initial treatment for another 6 months.
  • Behavioral: Interpersonal Psychotherapy
    Participants will receive interpersonal psychotherapy (IPT) for 8 months and possibly an additional 6 months.
  • Other: Escitalopram plus IPT
    Participants whose symptoms become stabilized will continue the initial treatment for another 6 months. Those who do not will have the second treatment added to their regimen until remission occurs.
Study Arms  ICMJE
  • Experimental: 1
    Interpersonal Psychotherapy
    Intervention: Behavioral: Interpersonal Psychotherapy
  • Experimental: 2
    Escitalopram
    Intervention: Drug: Escitalopram
  • Experimental: 3
    Escitalopram plus IPT
    Intervention: Other: Escitalopram plus IPT
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 23, 2005)
290
Original Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE October 2007
Actual Primary Completion Date October 2007   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Diagnosis of Major depression

Exclusion Criteria:

  • History of manic or hypomanic episodes
  • History of schizophrenia or schizoaffective disorder
  • Diagnosis of anorexia nervosa or bulimia nervosa
  • Current psychosis
  • Drug and/or alcohol dependence or abuse within 3 months prior to study entry. Participants with episodic abuse related to mood disorders will not be excluded.
  • Diagnosis of antisocial personality disorder
  • Diagnosis of organic affective syndrome and uncontrolled medical illness
  • Pregnancy
  • Require inpatient treatment for suicidal risk or psychosis
  • History of an inability to tolerate any of the study treatments
  • Currently receiving treatment with an effective antidepressant
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 66 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Italy,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00073697
Other Study ID Numbers  ICMJE R01MH065376( U.S. NIH Grant/Contract )
R01MH065376 ( U.S. NIH Grant/Contract )
DSIR 83-ATAS
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Ellen Frank, University of Pittsburgh
Study Sponsor  ICMJE University of Pittsburgh
Collaborators  ICMJE National Institute of Mental Health (NIMH)
Investigators  ICMJE
Principal Investigator: Ellen Frank University of Pittsburgh
PRS Account University of Pittsburgh
Verification Date January 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP