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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: Completed Phase 4 study, sponsored by Weill Medical College of Cornell University.
NCT01427608 is a Phase 4 study that has completed, run by Weill Medical College of Cornell University. The registered enrollment target is 269 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (48% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Relapse criteria include at least one of the following: 1)Structured Clinical Interview for Diagnostic Statistical Manual #4 Trade Revision (DSM-IV-TR) Axis 1 Disorders (SCID) symptoms of major depression maintained over two weeks 2)17-item Hamilton Depression Rating Scale score of \>17 maintained for more than one week + a mean increase of 5 points from entry into randomized phase 3)Re-emergence of psychosis for more than one week, with a SADS (Schedule for Affective Disorders and Schizophreni
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 |
What the finished NCT01427608 record still lists
NCT01427608 is an interventional study that assigns participants to a tested intervention. The registered 269 participants enrollment target is mid-sized for trials with a published cap, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (48% lower).
The record links to 0 conditions, and to 2 interventions - of which Sertraline + Olanzapine is the first listed.
NCT01427608 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01427608's enrollment target sits among peer trials
269 319th of 2000 higher than 1,682 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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