Ignite Creation Date:
2024-05-05 @ 12:03 PM
Last Modification Date:
2024-10-26 @ 9:19 AM
Study NCT ID:
NCT00227955
Status:
COMPLETED
Last Update Posted:
2013-06-25
First Post:
2005-09-26
Brief Title:
Comparing Various Treatments for Achieving and Maintaining Remission of Depression
Sponsor:
University of Pittsburgh
Organization:
University of Pittsburgh
Study Overview
Official Title:
Maintenance Therapies in Recurrent Depression-Study I
Status:
COMPLETED
Status Verified Date:
2013-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
Detailed Description:
Depression is a serious illness that can interfere with a persons 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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None