Depression, Depressive Disorder
Conditions
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.
Interventions
BEHAVIORALBrief Supportive Psychotherapy
brief supportive psychotherapy
BEHAVIORALCBASP
psychotherapy developed for chronic depression
DRUGMedication Only
antidepressant medication
Sponsors
National Institute of Mental Health (NIMH)
Weill Medical College of Cornell University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Remission | 12 weeks | Hamilton Depression Scale (HAM-D)\<8 and does not meet DSM-IV criteria for Major Depressive Disorder for 2 consecutive visits |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| CBASP Cognitive Behavioral Analysis System of Psychotherapy | 200 |
| Brief Supportive P Brief Supportive Psychotherapyherapy | 195 |
| Medication Only Sertraline
Escitalopram
Bupropion SR or XL
Venlafaxine XR
Mirtazapine | 96 |
| Total | 491 |
Baseline characteristics
| Characteristic | CBASP | Brief Supportive P | Medication Only | Total |
|---|---|---|---|---|
| Age, Continuous | 43.2 years STANDARD_DEVIATION 13.4 | 46.4 years STANDARD_DEVIATION 11.7 | 45.3 years STANDARD_DEVIATION 11.9 | 45.9 years STANDARD_DEVIATION 11.8 |
| Hamilton Depression Scale | 19.52 units on a scale STANDARD_DEVIATION 8.26 | 19.44 units on a scale STANDARD_DEVIATION 8.31 | 18.4 units on a scale STANDARD_DEVIATION 8.8 | 19.48 units on a scale STANDARD_DEVIATION 8.27 |
| Region of Enrollment United States | 200 participants | 195 participants | 96 participants | 491 participants |
| Sex: Female, Male Female | 112 Participants | 113 Participants | 47 Participants | 272 Participants |
| Sex: Female, Male Male | 88 Participants | 82 Participants | 49 Participants | 219 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 28 / 200 | 23 / 195 | 8 / 96 |
| serious Total, serious adverse events | 0 / 200 | 0 / 195 | 0 / 96 |
Outcome results
Primary
Remission
Hamilton Depression Scale (HAM-D)\<8 and does not meet DSM-IV criteria for Major Depressive Disorder for 2 consecutive visits
Time frame: 12 weeks
Population: Refers to # of subjects who completed 12 weeks of treatment
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| CBASP | Remission | 38.5 percentage of participants |
| Brief SP | Remission | 31.0 percentage of participants |
| Medication Only | Remission | 39.5 percentage of participants |