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NCT01427608 · ClinicalTrials.gov registry record · Phase 4
Sustaining Remission of Psychotic Depression
A Phase 4 study, sponsored by Weill Medical College of Cornell University.
- Completed
- Registry status
- Phase 4
- Development phase
- 269
- Enrollment target
NCT01427608 is a Phase 4 study that has completed, run by Weill Medical College of Cornell University. The registered enrollment target is 269 participants.
The verdict
NCT01427608, a Phase 4 study, has completed, sponsored by Weill Medical College of Cornell University.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 269 participants
- Enrollment target
Study Summary
The acute phase of this study will monitor the response to a combination of an atypical antipsychotic medication olanzapine with an antidepressant medication sertraline in the acute treatment of the disorder. It is predicted that this combination will improve symptoms of psychotic depression and be associated metabolic side effects. Factors that moderate tolerability will be monitored. Improvement in symptoms could take between 4 and 12 weeks, followed by a period of 8 weeks during which participants will continue to take the same medications to stabilize the remission from symptoms of psychotic depression. The maintenance phase will be a randomized, double-blind, placebo-controlled study of olanzapine for a period of up to 36 weeks to test whether continuing this combination decreases the risk of relapse and whether discontinuing the combination leads to improvement in metabolic measures. Subjects who complete the acute phase will be asked to consent separately to the randomized maintenance phase.
Interventions
- DRUG Sertraline + Olanzapine
- DRUG Sertraline + Placebo
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 269 participants |
| Start Date | 2011-10 |
| Est. Completion | 2017-11-30 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01427608
The ClinicalTrials.gov registry entry for NCT01427608 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 269 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Weill Medical College of Cornell University, which has 701 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Sertraline + Olanzapine is the first listed.
NCT01427608 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01427608 about?
NCT01427608 is a clinical study titled "Sustaining Remission of Psychotic Depression". The acute phase of this study will monitor the response to a combination of an atypical antipsychotic medication olanzapine with an antidepressant medication sertraline in the acute treatment of the disorder. It is predicted that this combination will improve symptoms of psychotic depression and be ...
What is the current status of trial NCT01427608?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 269 participants. The study started on 2011-10. Estimated completion is 2017-11-30.
What interventions are being tested in trial NCT01427608?
The interventions under investigation include: Sertraline + Olanzapine (DRUG), Sertraline + Placebo (DRUG).
Who is sponsoring clinical trial NCT01427608?
This trial is sponsored by Weill Medical College of Cornell University, which has 701 total clinical trials registered on ClinicalTrials.gov.
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