|
|
Home
Search
Study Topics
Glossary
|
 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|||||||||||||||||||||||||||||||||||||||||||||
| Sponsored by: |
National Institute of Mental Health (NIMH) |
|---|---|
| Information provided by: | National Institute of Mental Health (NIMH) |
| ClinicalTrials.gov Identifier: | NCT00227955 |
Purpose
This study will evaluate the effectiveness of five combinations of drug therapy and psychotherapy in maintaining remission of depression symptoms in people with recurrent major depression.
| Condition | Intervention | Phase |
|---|---|---|
|
Depression |
Drug: Imipramine Behavioral: Interpersonal Psychotherapy |
Phase IV |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Open Label, Active Control, Crossover Assignment, Efficacy Study |
| Official Title: | Maintenance Therapies in Recurrent Depression-Study I |
| Estimated Enrollment: | 200 |
| Study Start Date: | December 1987 |
| Estimated Study Completion Date: | December 1993 |
Depression is a serious illness that can interfere with a person’s ability to work, study, sleep, eat, and enjoy activities that once were pleasurable. It is characterized by several symptoms, such as the following: persistent sad, anxious, or "empty" mood; feelings of hopelessness or pessimism; and feelings of guilt, worthlessness, or helplessness. If left untreated, depression symptoms can last for years, and may worsen as time goes on. Even with treatment, however, it is possible for depression to recur. Remission is a main goal in the treatment of depression and it may be accomplished through various strategies. This study will evaluate the effectiveness of five combinations of treatments, including medication therapy and psychotherapy, in maintaining remission of depression symptoms.
All participants in this study will first be treated with imipramine for 7 to 11 months. Once remission of depression symptoms has been achieved and maintained for 20 weeks, participants will be randomly assigned to one of the following five maintenance treatments for 36 months: psychotherapy plus imipramine; psychotherapy plus placebo; psychotherapy alone; medication clinic treatment plus imipramine; or medication clinic treatment plus placebo. Assessments will be made at Weeks 12 and 20 and Months 7, 11, and 36, and will include the time it takes for depression symptoms to recur, as well as scores on depression and mania severity scales.
Eligibility| Ages Eligible for Study: | 21 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| United States, Pennsylvania | |
| Western Psychiatric Institute and Cinic | |
| Pittsburgh, Pennsylvania, United States, 15213 | |
| Principal Investigator: | Ellen Frank, PhD | University of Pittsburgh |
More Information
| Study ID Numbers: | 871250 |
| Study First Received: | September 26, 2005 |
| Last Updated: | April 21, 2006 |
| ClinicalTrials.gov Identifier: | NCT00227955 |
| Health Authority: | United States: Federal Government |
|
Major depression |
|
Imipramine Depression Mental Disorders Mood Disorders |
Depressive Disorder, Major Depressive Disorder Recurrence Behavioral Symptoms |
|
Neurotransmitter Uptake Inhibitors Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Adrenergic Agents Adrenergic Uptake Inhibitors Therapeutic Uses |
Physiological Effects of Drugs Psychotropic Drugs Central Nervous System Agents Pharmacologic Actions Antidepressive Agents Antidepressive Agents, Tricyclic |
