Depression
Conditions
Keywords
Major Depressive Disorder
Brief summary
This 4-8 month study, with a 2-year follow up period, will compare sertraline (Zoloft®), venlafaxine (Effexor®), supportive-expressive psychotherapy, and placebo to determine which is more effective in treating major depression.
Detailed description
MDD is one of the most prevalent psychiatric disorders. Different forms of psychotherapy for depression have been found effective. This study compares a form of dynamic psychotherapy called supportive-expressive psychotherapy to medication and to placebo. Participants are evaluated on 2 occasions, 1 week apart, before they are randomly assigned to receive either supportive-expressive psychotherapy, sertraline (Zoloft) (followed by venlafaxine \[Effexor\] if patients do not respond to sertraline), or placebo. The active phase of treatment lasts 4 months. The frequency of patients' visits depends on the assigned treatment. Patients who are randomized to receive medication or placebo are initially seen on a weekly basis, then less often, depending on the rate of symptomatic improvement. Patients who are randomized to psychotherapy are seen twice a week for the first 4 weeks, then once a week for the remaining 12 weeks. Outcome is monitored at week 2,4,6,7,8, 12, 15 and 16. At the end of the first 16 weeks of treatment, patients are thoroughly evaluated. Those who have responded to treatment are assigned to a continuation phase and are seen once a month for another 16 weeks. At the end of the 16-week continuation phase, patients are again evaluated and all treatments are stopped. Follow-up continues every 3 months for up to 2 years to ensure that the patients' depression remains under control.
Interventions
BEHAVIORALSupportive Expressive Therapy
The aim of supportive-expressive psychotherapy is to help patients understand the causes of relationship conflicts in the context of a supportive relationship.
DRUGSertraline
Participants will receive sertraline.
DRUGPill Placebo
Participants will receive a pill placebo.
DRUGVenlafaxine
Participants will receive venlafaxine.
Sponsors
National Institute of Mental Health (NIMH)
University of Pennsylvania
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Major Depressive Disorder diagnosis
Exclusion criteria
* Psychotic or bipolar disorder diagnosis * Substance dependence in the last 6 months
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Hamilton Rating Scale for Depression-17 Item | symptoms assessed during past 7 days, measure taken at baseline, week 8 and week 16 | Hamilton Rating Scale for Depression (HRSD) (Hamilton, 1960). We used the 17-item version of the 27-item HRSD, a measure of depression severity. The Structured Interview Guide was used to conduct the interviews (SIGH-D; Williams, 1988). The reliability and validity of the HRSD are well documented (Rabkin & Klein, 1987). Interjudge reliability as assessed by interclass correlations was .92 in our sample. Total 17-item scores could range from 17-48 with higher scores indicating greater distress. |
Countries
United States
Participant flow
Recruitment details
374 individuals, ages 18 to 70 years, were recruited through advertisements on public transportation, free news publications, area physicians, and outpatient clinics during the period of 2001-2006.
Pre-assignment details
Individuals not meeting MDD diagnostic criteria11 using the Structured Clinical Interviews for DSM-IV12 or scoring less than 14 on the 17-item Hamilton Rating Scale for Depression (HRSD)13,14 at two evaluations one week apart were excluded (n=88).
Participants by arm
| Arm | Count |
|---|---|
| 1 Sertraline Participants receive sertraline.
Sertraline : Participants will receive sertraline. | 55 |
| 2 Supportive-expressive Psychotherapy Participants will receive supportive-expressive psychotherapy.
Supportive Expressive Therapy : The aim of supportive-expressive psychotherapy is to help patients understand the causes of relationship conflicts in the context of a supportive relationship. | 51 |
| 3 Pill Placebo Participants receive placebo.
Pill Placebo : Participants will receive a pill placebo. | 50 |
| Total | 156 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Withdrawal by Subject | 22 | 12 | 20 |
Baseline characteristics
| Characteristic | 2 Supportive-expressive Psychotherapy | 3 Pill Placebo | 1 Sertraline | Total |
|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 51 Participants | 50 Participants | 55 Participants | 156 Participants |
| Age, Continuous | 36.2 years STANDARD_DEVIATION 12.2 | 38.3 years STANDARD_DEVIATION 12 | 38.0 years STANDARD_DEVIATION 12.5 | 37.5 years STANDARD_DEVIATION 12.2 |
| Region of Enrollment United States | 51 participants | 50 participants | 55 participants | 156 participants |
| Sex: Female, Male Female | 31 Participants | 31 Participants | 30 Participants | 92 Participants |
| Sex: Female, Male Male | 20 Participants | 19 Participants | 25 Participants | 64 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 | 0 / 55 | 1 / 51 | 0 / 50 |
| serious Total, serious adverse events | 0 / 55 | 0 / 51 | 0 / 50 |
Outcome results
Primary
Hamilton Rating Scale for Depression-17 Item
Hamilton Rating Scale for Depression (HRSD) (Hamilton, 1960). We used the 17-item version of the 27-item HRSD, a measure of depression severity. The Structured Interview Guide was used to conduct the interviews (SIGH-D; Williams, 1988). The reliability and validity of the HRSD are well documented (Rabkin & Klein, 1987). Interjudge reliability as assessed by interclass correlations was .92 in our sample. Total 17-item scores could range from 17-48 with higher scores indicating greater distress.
Time frame: symptoms assessed during past 7 days, measure taken at baseline, week 8 and week 16
Population: Numbers vary from consented due to dropout prior to start of study. 156 patients consented and randomized. 11 patients did not complete at least one post-randomization measure and were therefore not included in these analyses.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| 1 Sertraline | Hamilton Rating Scale for Depression-17 Item | LOCF HRSD-17 | 14.2 units on a scale | Standard Deviation 7.6 |
| 1 Sertraline | Hamilton Rating Scale for Depression-17 Item | Mid-treatment HRSD-17 | 13.9 units on a scale | Standard Deviation 7.2 |
| 1 Sertraline | Hamilton Rating Scale for Depression-17 Item | Initial HRSD-17 | 19.0 units on a scale | Standard Deviation 3.4 |
| 2 Supportive-expressive Psychotherapy | Hamilton Rating Scale for Depression-17 Item | LOCF HRSD-17 | 14.5 units on a scale | Standard Deviation 8.3 |
| 2 Supportive-expressive Psychotherapy | Hamilton Rating Scale for Depression-17 Item | Initial HRSD-17 | 19.9 units on a scale | Standard Deviation 3.9 |
| 2 Supportive-expressive Psychotherapy | Hamilton Rating Scale for Depression-17 Item | Mid-treatment HRSD-17 | 12.5 units on a scale | Standard Deviation 6.9 |
| 3 Pill Placebo | Hamilton Rating Scale for Depression-17 Item | Mid-treatment HRSD-17 | 12.7 units on a scale | Standard Deviation 6.8 |
| 3 Pill Placebo | Hamilton Rating Scale for Depression-17 Item | Initial HRSD-17 | 19.4 units on a scale | Standard Deviation 3.7 |
| 3 Pill Placebo | Hamilton Rating Scale for Depression-17 Item | LOCF HRSD-17 | 14.3 units on a scale | Standard Deviation 7.6 |
Comparison: Comparison of conditionsp-value: 0.95HLM
Comparison: effects of conditions over timep-value: <0.0001HLM
95% CI: [-0.35, 0.41]
95% CI: [-0.33, 0.45]