| Home | Search | Study Topics | Glossary |
|
|
|
 |
 |
|
|
|
|
|
|
|
|
|
|
|
|
|
||||||||||||||||||||||||||||||||||||
| Descriptive Information Fields | |||||||||
| Brief Title † | Cognitive Therapy Versus Medication Treatment for Preventing Depression Relapse | ||||||||
| Official Title † | Are CT's Effects Durable? | ||||||||
| Brief Summary | This study will evaluate the longer term effectiveness of cognitive therapy (CT) versus medication treatment or placebo for prevention of recurrence of depression for 24 months after termination of continuation phase therapy. |
||||||||
| Detailed Description | Depression is a serious medical illness that is often difficult to diagnose and treat. It often recurs more than once in a person's lifetime. Effective treatment methods are needed to prevent the relapse in people who have had prior episodes of depression. CT is a short-term talking therapy that focuses on changing negative thinking patterns and helping patients develop coping skills to deal with their experiences. Evidence suggests that CT is effective in treating a number of psychiatric conditions, including anxiety and anger. This study will determine the effectiveness of booster sessions of CT versus antidepressant medication in preventing relapse of depression in people at risk for recurrent depression. All participants in this double blind study will first receive 16 to 20 sessions of cognitive-behavioral therapy over 12 weeks. Participants who respond to the treatment, but do not achieve full remission of depressive symptoms, will be considered to be at risk for relapse. They will be randomly assigned to receive 10 booster sessions of one of three treatments over 8 months: cognitive-behavioral therapy, fluoxetine, or placebo. The booster sessions will take place twice monthly for the first 2 months and once monthly for the next 6 months. All participants who complete the entire 8 months of the study will be followed-up for an additional 2 years to monitor depressive relapse and psychosocial functioning. |
||||||||
| Study Phase | |||||||||
| Study Type † | Interventional | ||||||||
| Study Design † | Treatment, Randomized, Double Blind (Subject, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study | ||||||||
| Primary Outcome Measure † | Depressive relapse [ Time Frame: Measured at Month 24 ] [ Designated as safety issue: No ] | ||||||||
| Secondary Outcome Measure † | Psychosocial functioning [ Time Frame: Measured at Month 24 ] [ Designated as safety issue: No ] | ||||||||
| Condition † | Depression | ||||||||
| Intervention † | Drug: Fluoxetine (Prozac) Behavioral: Cognitive therapy (CT) Drug: Placebo |
||||||||
| MEDLINE PMIDs | |||||||||
| Links | |||||||||
| Recruitment Information Fields | |||||||||
| Recruitment Status † | Recruiting | ||||||||
| Enrollment † | 500 | ||||||||
| Start Date † | December 2003 | ||||||||
| Completion Date | December 2012 | ||||||||
| Eligibility Criteria † | Inclusion Criteria:
Exclusion Criteria:
|
||||||||
| Gender | Both | ||||||||
| Ages | 18 Years to 70 Years | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts †† |
|
||||||||
| Location Countries † | United States | ||||||||
| Administrative Information Fields | |||||||||
| NCT ID † | NCT00218764 | ||||||||
| Organization ID | R01 MH69618 | ||||||||
| Secondary IDs †† | DSIR 83-ATSO | ||||||||
| Study Sponsor † | National Institute of Mental Health (NIMH) | ||||||||
| Collaborators †† | |||||||||
| Investigators † |
|
||||||||
| Information Provided By | National Institute of Mental Health (NIMH) | ||||||||
| Verification Date | February 2008 | ||||||||
| First Received Date † | September 21, 2005 | ||||||||
| Last Updated Date | February 12, 2008 | ||||||||
|
