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
|Condition or disease||Intervention/treatment||Phase|
|Depression||Drug: Escitalopram Behavioral: Interpersonal Psychotherapy Other: Escitalopram plus IPT||Phase 4|
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 :||Interventional (Clinical Trial)|
|Actual Enrollment :||290 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||None (Open Label)|
|Official Title:||Depression: The Search for Treatment-Relevant Phenotypes|
|Study Start Date :||May 2003|
|Actual Primary Completion Date :||October 2007|
|Actual Study Completion Date :||October 2007|
Behavioral: Interpersonal Psychotherapy
Participants will receive interpersonal psychotherapy (IPT) for 8 months and possibly an additional 6 months.
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.
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.
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00073697
|United States, Pennsylvania|
|Western Psychiatric Institute and Clinic - Depression Prevention Program|
|Pittsburgh, Pennsylvania, United States, 15213|
|The University of Pisa|
|Principal Investigator:||Ellen Frank||University of Pittsburgh|