Prevention of Recurrence in Depression With Drugs and CT

Depression Clinical Trial

— CPT3  

Official title:

Prevention of Recurrence in Depression With Drugs and CT

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00057577
• Other study ID #: R01MH060713
• Secondary ID: R01MH060713
• Status: Completed
• Phase: Phase 4
• First received: April 4, 2003
• Last updated: May 22, 2017
• Start date: October 2002
• Est. completion date: March 2014

Study information

• Verified date: May 2017
• Source: Vanderbilt University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study will determine whether the addition of Cognitive Therapy (CT) to antidepressant medication (ADM) enhances treatment for depression. This study will also test whether the addition of CT to ADM will prevent recurrences of depression after therapy is over.

Description:

It is commonly believed that the combination of ADM and psychotherapy is more effective in treating depression than either treatment alone. Data indicate that CT enhances the initial effects of ADM, but little research has been conducted to determine whether prior exposure to CT prevents the onset of new depressive episodes. This study will determine the effectiveness of adding CT to ADM for the treatment of depression.

Participants are randomly assigned to receive either ADM alone or ADM plus CT for up to 18 months. Remitted patients are continued on medication for up to 36 months from the point of initial randomization until they meet criteria for recovery. At recovery, patients receiving combined treatment discontinue cognitive therapy; all recovered patients are randomized a second time to either maintenance medication or medication withdrawal. Patients are then monitored over 36 months to ascertain risk for recurrence of depressive symptoms.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 452
• Est. completion date: March 2014
• Est. primary completion date: July 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Recurrent or chronic major depressive disorder

Exclusion Criteria:

• Current diagnosis of psychotic affective disorder

• History of nonaffective psychotic disorder

• Substance dependence last three months requiring detox

• Schizotypal, antisocial, or borderline personality disorder

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Recurrence

Intervention

Behavioral:
• Cognitive Therapy
CT sessions occur weekly during acute treatment and monthly during continuation. Acute treatment may last up to 18 months. Remitted patients are continued on medication for up to 36 months from initial randomization until they meet criteria for recovery. At recovery, patients receiving combined treatment discontinue CT.

Drug:
• Medications
Antidepressant medication is distributed as clinically indicated with augmentation and ancillary medications as needed. Acute treatment may last up to 18 months. Remitted patients are continued on medication for up to 36 months from the point of initial randomization until they meet criteria for recovery. All recovered patients are randomized a second time to either maintenance medication or medication withdrawal. Patients are then monitored over 36 months to ascertain risk for recurrence of depressive symptoms.

Locations

Country	Name	City	State
United States	Rush Medical Center - Treatment Research Unit	Chicago	Illinois
United States	Vanderbilt Adult Outpatient Psychiatry	Nashville	Tennessee
United States	Depression Research Unit, University of Pennsylvania	Philadelphia	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
Vanderbilt University	National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Serious Adverse Events	Number Serious Adverse Events (SAEs) as reported to the Institutional Review Boards and Data Safety Monitoring Board throughout the duration of the study	Throughout study, up to 54 months
Primary	Number of Participants in Remission According to the Longitudinal Interval Follow-up Evaluation (LIFE) and the Hamilton Rating Scale for Depression (HRSD)	Remission defined as four consecutive weeks of LIFE Problem Symptom Rating (PSR) values of 2 or less and HRSD scores of 8 or less for four consecutive weeks (with partial remission defined as LIFE PSR values of 3 or less and HRSD scores of 12 or less after month 12 only)	Through month 18 of treatment
Primary	Number of Participants in Recovery According to the LIFE and HRSD	Six consecutive months following remission without relapse (two weeks of elevated LIFE PSR scores of 4 or more and HRSD scores of 14 and above)	Through 36 months of treatment
Primary	Number of Participants in Recurrence According to the LIFE and HRSD	Recurrence defined as two consecutive weeks of elevated LIFE PSR scores of 5 or above and HRSD scores of 16 or above (three weeks during period of medication withdrawal)	Measured up to Month 36 from recovery