Research Evaluating the Value of Augmenting Medication With Psychotherapy

Study Overview
=================
Brief Summary
-----------------
This 24-week study, with a 12-month follow up period, will compare the effectiveness of antidepressant medication alone to the combination of psychotherapy and antidepressant medication in patients with chronic depression.

Detailed Description
-----------------
Chronic depression affects approximately 5% of adults in the United States and is associated with significant functional impairment and high health care utilization. The combination of drug treatment and psychotherapy may be most effective in treating depression. This study will determine the effects of adjunctive psychotherapy in depressed patients who have failed to respond or have responded only partially to an initial trial medication. Participants receive an initial trial of antidepressant medication for 8 to 12 weeks. Participants who continue to have depressive symptoms are randomly assigned to add Cognitive Behavioral Analysis System of Psychotherapy (CBASP) or supportive therapy to their medication regimens or to continue pharmacotherapy alone for an additional 12 weeks. Assessments are made at 6 and 12 months post-treatment.

Official Title
-----------------
CBASP Augmentation for Treatment of Chronic Depression

Conditions
-----------------
Depression, Depressive Disorder

Intervention / Treatment
-----------------
* Behavioral: Brief Supportive Psychotherapy
* Behavioral: CBASP
* Drug: Medication Only


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria Major depressive episode Depressive symptoms > 2 years without remission Hamilton Depression Scale (HAM-D) score > 20 Fluent in English Exclusion Criteria Psychotic disorders, bipolar disorder, post traumatic stress disorder, obsessive compulsive disorder, or eating disorder Serious, unstable, or terminal medical condition Axis II diagnosis of antisocial, schizotypal, or severe borderline personality disorder Previous treatment with CBASP Previous ineffective treatment with 4 of the medication treatments used in the study Substance abuse Pregnancy Not willing to end other psychiatric treatment

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CBASP<br>Cognitive Behavioral System of Psychotherapy plus medication (Could be switch to or addition of escitalopram, bupropion, venlafaxine or mirtazapine) | Behavioral: CBASP<br>* psychotherapy developed for chronic depression<br>* Other names: Cognitive Behavioral Analysis System of Psychotherapy;|
| Active Comparator: Brief Supportive Psychotherapy<br>Brief Supportive Psychotherapy plus medication (Could be switch to or addition of escitalopram, bupropion, venlafaxine or mirtazapine) | Behavioral: Brief Supportive Psychotherapy<br>* brief supportive psychotherapy<br>|
| Active Comparator: Medication Only<br>Could be switch to or addition of escitalopram, bupropion, venlafaxine or mirtazapine | Drug: Medication Only<br>* antidepressant medication<br>* Other names: one of five antidepressants;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Remission | Hamilton Depression Scale (HAM-D)<8 and does not meet DSM-IV criteria for Major Depressive Disorder for 2 consecutive visits | 12 weeks |