Phase 3
N=241
Cognitive Therapy for Recurrent Depression
Depression
Bottom Line
View on ClinicalTrials.gov: NCT00118404 ↗Enrolled (actual)
241
Serious AEs
0.0%
Results posted
Jun 2014
Primary outcome: Primary: Depressive Relapse or MDD — 18; 18.3; 32.7 % patients who relapsed — p=.42
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Continuation phase cognitive therapy (Behavioral); Continuation phase fluoxetine (Drug); Continuation phase pill placebo (Other); Acute phase cognitive therapy (Behavioral)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Texas Southwestern Medical Center
- Primary completion
- Jul 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Depressive Relapse or MDD |
18; 18.3; 32.7 | .42 |
| PRIMARY Depressive Relapse/Recurrence or MDD |
41.1; 45.2; 56.3 | .40 |
| PRIMARY Depressive Relapse/Recurrence or MDD |
41.1; 45.2; 56.3 | .40 |
Summary
This study determined the effectiveness of continuation phase cognitive therapy versus antidepressant medication in preventing relapse of depression in people with recurrent depression.
Eligibility Criteria
Inclusion Criteria
- Recurrent unipolar major depressive disorder
- Have experienced at least two episodes of major depression
- Have experienced at least one period of recovery during a depressive episode or have a history of dysthymia (a mood disorder characterized by depression) prior to the onset of current or past depressive episodes
- Willing and able to comply with all study requirements
- Able to speak and read English
Exclusion Criteria
- Active alcohol or other substance dependence within 6 months prior to study entry
- Currently at risk for suicide
- Mood disorders due to a medical condition or substance abuse
- Bipolar, schizoaffective, obsessive compulsive, or eating disorders
- Schizophrenia
- Unable to stop mood-altering medications
- Current use of medication or diagnosis of a medical disorder that may cause depression (e.g., diabetes, head injury, stroke, cancer, multiple sclerosis)
- Previous failure to experience a reduction in depressive symptoms after 8 weeks of cognitive therapy with a certified therapist
- Previous failure to experience a reduction in depressive symptoms after 6 weeks of 40 mg of Prozac
- Pregnancy or plan to become pregnant in the next 11-12 months
- Unable to attend clinic twice weekly during business hours
- Unable to complete questionnaires
Data sourced from ClinicalTrials.gov (NCT00118404). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.