Depression: The Search for Treatment-Relevant Phenotypes-Pilot Study

NCT00222820 | Completed Phase 4

• 1 other identifier: 011015
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

Brief Summary

We are doing this pilot study to learn more about four aspects of treating depression:

1. 1.The features of a depressed person's mood and anxiety and how these features affect a person's capacity to get better and stay better.
2. 2.If depressed people with certain features of mood and anxiety respond better to therapy, medication or a combination of therapy and medication.
3. 3.Whether or not a person's personality traits affect how they respond to treatment.
4. 4.The gene involved in processing antidepressant medication

Conditions

Major Depression

Outcome Measures

Primary Outcomes (1)

• Hamilton Rating Scale for Depression

Secondary Outcomes (1)

• Inventory of Depressive Symptoms

Interventions

escitalopram DRUG

Interpersonal Psychotherapy BEHAVIORAL

Eligibility Criteria

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

You may qualify if:

• \. Men and women 2 Age 18-65 3. Currently experiencing an episode of major depression 4. Not currently receiving effective treatment 5. Females of childbearing potential: practicing an acceptable form of birth control 6. Subjects with suicidal ideation are eligible as long as outpatient treatment is deemed safe 7. Willingness and ability to give informed consent.

You may not qualify if:

• History of manic or hypomanic episodes;
• History of schizophrenia or schizoaffective disorder;
• Current primary diagnosis of anorexia nervosa or bulimia nervosa;
• Current psychosis;
• Drug and/or alcohol dependence or abuse within the past three months (episodic abuse related to mood episodes will not exclude a subject);
• Organic affective syndrome;
• Renal or liver disease;
• Epilepsy;
• Cardiovascular disease;
• Uncontrolled illnesses, including untreated hypertension or unstable endocrine diseases.
• Women who are or are plan to become pregnant during the course of this study
• Subjects who require inpatient treatment because of suicidal risk or psychosis
• Subjects with a well-documented history of an inability to tolerate one of the study treatments or are currently receiving treatment with an effective antidepressant therapy

Sponsors & Collaborators

• University of Pittsburgh: lead
• Mental Health Intervention Research Center (MHIRC): collaborator

Study Sites (1)

Western Psychaitric Institute and Clinic

Pittsburgh, Pennsylvania, 15213, United States

Location

MeSH Terms

Conditions

Depressive Disorder, Major

Interventions

Escitalopram; Interpersonal Psychotherapy

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Propylamines; Amines; Organic Chemicals; Nitriles; Benzofurans; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Ellen Frank, Ph.D.

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 13, 2005
• First Posted: September 22, 2005
• Study Start: April 1, 2002
• Study Completion: September 1, 2004
• Last Updated: September 22, 2005

Record last verified: 2005-09

Locations

US (1)