Treatment of Depression in Adults

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
University of Pittsburgh
ClinicalTrials.gov Identifier:
NCT00073697
First received: December 2, 2003
Last updated: January 10, 2012
Last verified: January 2012

December 2, 2003
January 10, 2012
May 2003
October 2007   (final data collection date for primary outcome measure)
  • Hamilton Rating Scale for Depression score [ Time Frame: Measured at Months 8 and 14 ] [ Designated as safety issue: No ]
  • Treatment-relevant phenotypes of depression [ Time Frame: Measured at Months 8 and 14 ] [ Designated as safety issue: No ]
Not Provided
Complete list of historical versions of study NCT00073697 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Treatment of Depression in Adults
Depression: The Search for Treatment-Relevant Phenotypes

This study will determine how certain features of depressed individuals affect their responses to depression treatment.

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.

Interventional
Phase 4
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Depression
  • 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.
  • Experimental: 1
    Interpersonal Psychotherapy
    Intervention: Behavioral: Interpersonal Psychotherapy
  • Experimental: 2
    Escitalopram
    Intervention: Drug: Escitalopram
  • Experimental: 3
    Escitalopram plus IPT
    Intervention: Other: Escitalopram plus IPT
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
290
October 2007
October 2007   (final data collection date for primary outcome measure)

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
Both
18 Years to 66 Years
No
Contact information is only displayed when the study is recruiting subjects
Italy,   United States
 
NCT00073697
R01 MH65376, R01MH065376, DSIR 83-ATAS
Not Provided
Ellen Frank, University of Pittsburgh
University of Pittsburgh
National Institute of Mental Health (NIMH)
Principal Investigator: Ellen Frank University of Pittsburgh
University of Pittsburgh
January 2012

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