Ignite Creation Date:
2024-05-05 @ 11:26 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00043550
Status:
COMPLETED
Last Update Posted:
2017-06-02
First Post:
2002-08-09
Brief Title:
Treatments for Depression Drug Versus Psychotherapy
Sponsor:
University of Pennsylvania
Organization:
University of Pennsylvania
Study Overview
Official Title:
Efficacy of Dynamic Therapy Versus Selective Serotonin Reuptake Inhibitor for Depression
Status:
COMPLETED
Status Verified Date:
2017-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 24678 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
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 24678 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| DSIR 83-ATAS | US NIH GrantContract | None | httpsreporternihgovquickSearchR01MH061410 |
| R01MH061410 | NIH | None | None |