Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
290 participants
INTERVENTIONAL
2003-05-31
2007-10-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
NONE
Study Groups
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1
Interpersonal Psychotherapy
Interpersonal Psychotherapy
Participants will receive interpersonal psychotherapy (IPT) for 8 months and possibly an additional 6 months.
2
Escitalopram
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.
3
Escitalopram plus IPT
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.
Interventions
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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.
Interpersonal Psychotherapy
Participants will receive interpersonal psychotherapy (IPT) for 8 months and possibly an additional 6 months.
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.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* 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
18 Years
66 Years
ALL
No
Sponsors
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National Institute of Mental Health (NIMH)
NIH
University of Pittsburgh
OTHER
Responsible Party
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University of Pittsburgh
Principal Investigators
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Ellen Frank
Role: PRINCIPAL_INVESTIGATOR
University of Pittsburgh
Locations
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Western Psychiatric Institute and Clinic - Depression Prevention Program
Pittsburgh, Pennsylvania, United States
The University of Pisa
Pisa, , Italy
Countries
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Other Identifiers
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