Depression: The Search for Treatment-Relevant Phenotypes
Escitalopram
+ Interpersonal Psychotherapy
+ Escitalopram plus IPT
Mental Disorders+2
+ Behavioral Symptoms
+ Depression
Treatment Study
Summary
Study start date: May 1, 2003
Actual date on which the first participant was enrolled.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.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.290 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.From 18 to 66 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
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
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.3 intervention groups are designated in this study
This study does not include a placebo group
Treatment Groups
Group I
ExperimentalGroup II
ExperimentalGroup III
ExperimentalStudy Objectives
Primary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 2 locations
Western Psychiatric Institute and Clinic - Depression Prevention Program
Pittsburgh, United StatesSee the locationThe University of Pisa
Pisa, Italy