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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
  Purpose

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


Condition Intervention Phase
Depression
Drug: Escitalopram
Behavioral: Interpersonal Psychotherapy
Other: Escitalopram plus IPT
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Depression: The Search for Treatment-Relevant Phenotypes

Resource links provided by NLM:


Further study details as provided by University of Pittsburgh:

Primary Outcome Measures:
  • 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 ]

Enrollment: 290
Study Start Date: May 2003
Study Completion Date: October 2007
Primary Completion Date: October 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Interpersonal Psychotherapy
Behavioral: Interpersonal Psychotherapy
Participants will receive interpersonal psychotherapy (IPT) for 8 months and possibly an additional 6 months.
Experimental: 2
Escitalopram
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.
Experimental: 3
Escitalopram plus IPT
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years to 66 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00073697

Locations
United States, Pennsylvania
Western Psychiatric Institute and Clinic - Depression Prevention Program
Pittsburgh, Pennsylvania, United States, 15213
Italy
The University of Pisa
Pisa, Italy
Sponsors and Collaborators
University of Pittsburgh
Investigators
Principal Investigator: Ellen Frank University of Pittsburgh
  More Information

No publications provided

Responsible Party: Ellen Frank, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT00073697     History of Changes
Other Study ID Numbers: R01 MH65376, R01MH065376, DSIR 83-ATAS
Study First Received: December 2, 2003
Last Updated: January 10, 2012
Health Authority: United States: Federal Government

Keywords provided by University of Pittsburgh:
Psychotherapy
Depressive disorder
Antidepressive agents
Citalopram

Additional relevant MeSH terms:
Depression
Depressive Disorder
Behavioral Symptoms
Mental Disorders
Mood Disorders
Citalopram
Dexetimide
Anti-Dyskinesia Agents
Antidepressive Agents
Antidepressive Agents, Second-Generation
Antiparkinson Agents
Autonomic Agents
Central Nervous System Agents
Cholinergic Agents
Cholinergic Antagonists
Molecular Mechanisms of Pharmacological Action
Muscarinic Antagonists
Neurotransmitter Agents
Neurotransmitter Uptake Inhibitors
Parasympatholytics
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Psychotropic Drugs
Serotonin Agents
Serotonin Uptake Inhibitors
Therapeutic Uses

ClinicalTrials.gov processed this record on November 25, 2014