Cognitive Therapy Versus Medication Treatment for Preventing Depression Relapse

Depression Clinical Trial

Official title:

Are CT's Effects Durable?

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00218764
• Other study ID #: R01MH069618
• Secondary ID: DSIR 83-ATSO
• Status: Active, not recruiting
• Phase: N/A
• First received: September 21, 2005
• Last updated: October 21, 2008
• Start date: December 2003
• Est. completion date: December 2010

Study information

• Verified date: October 2008
• Source: National Institute of Mental Health (NIMH)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 500
• Est. completion date: December 2010
• Est. primary completion date: December 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• Diagnosis of recurrent unipolar major depressive disorder

• At least 2 episodes of major depression within lifetime, including present episode

• Speaks and reads English

• Seeking cognitive therapy treatment

• At least one period of complete inter-episode recovery or a history of dysthymia prior to the onset of the presenting or past episodes

Exclusion Criteria:

• Active alcohol or other substance dependence within the 6 months prior to study entry

• Active suicidal ideation with possible intent or probable risk

• Mood disorder due to a medical condition or substance use, bipolar disorder, schizophrenia, or schizoaffective disorder

• Unable to stop mood altering medications

• Concurrent medication or exclusionary medical disorders (diabetes, head injury, stroke, cancer, multiple sclerosis) that may cause depression

• Unable to attend clinic during business hours (Monday-Thursday, 8am-5pm) twice weekly

• Unable to complete questionnaires

• Unsuccessful treatment after 8 weeks of cognitive therapy with a certified therapist

• Unsuccessful treatment after 6 weeks of 40 mg of fluoxetine (Prozac)

• Pregnant or plans to become pregnant in the next 11-12 months

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Depression

Intervention

Drug:
• Fluoxetine (Prozac)
Fluoxetine 10 to 40 mg/day for 8 months

Behavioral:
• Cognitive therapy (CT)
Participants will attend CT sessions every-other week for 8 weeks, then monthly for 6 months.

Drug:
• Placebo
Placebo daily for 8 months

Locations

Country	Name	City	State
United States	The University of Texas Southwestern Medical Center at Dallas	Dallas	Texas
United States	University of Pennsylvania School of Medicine	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Depressive relapse		Measured at Month 24	No
Secondary	Psychosocial functioning		Measured at Month 24	No