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NCT01920802 · ClinicalTrials.gov registry record · Phase 4
Assessment and Comparison of Metabolic Changes in Non-psychotic Adults Taking Iloperidone or Olanzapine or Placebo
A Phase 4 study, sponsored by New York State Psychiatric Institute.
- Completed
- Registry status
- Phase 4
- Development phase
- 31
- Enrollment target
NCT01920802 is a Phase 4 study that has completed, run by New York State Psychiatric Institute. The registered enrollment target is 31 participants.
The verdict
NCT01920802, a Phase 4 study, has completed, sponsored by New York State Psychiatric Institute.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 31 participants
- Enrollment target
Study Summary
The purpose of this pilot randomized clinical trial is to begin to delineate the pathophysiological changes associated with antipsychotic associated metabolic side effects. The study will be performed in 36 healthy people between the ages of 18 and 30, who have never taken an antipsychotic, will undergo baseline laboratory tests before being randomized to 5mg BID of olanzapine or 6mg BID of iloperidone or placebo to take for up to 4 weeks. The primary outcome measure will be a correlation of early changes in leptin with weight gain. We will also record changes in food intake, resting metabolic rate, oral glucose tolerance and fasting insulin and glucose levels, lipids and inflammation markers. Subjects will be followed closely to monitor for safety throughout the 4-week study and will be discontinued if there is a medically significant change in metabolic status or other antipsychotic side effects. Metabolic assessments will be performed again at the time of discontinuation or at the end of an 4-week period, and change from baseline in the two treatment groups will be compared.
Interventions
- DRUG Placebo
- DRUG iloperidone
- DRUG olanzapine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 31 participants |
| Start Date | 2012-11 |
| Est. Completion | 2014-09 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01920802
The ClinicalTrials.gov registry entry for NCT01920802 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 31 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is New York State Psychiatric Institute, which has 364 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT01920802 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01920802 about?
NCT01920802 is a clinical study titled "Assessment and Comparison of Metabolic Changes in Non-psychotic Adults Taking Iloperidone or Olanzapine or Placebo". The purpose of this pilot randomized clinical trial is to begin to delineate the pathophysiological changes associated with antipsychotic associated metabolic side effects. The study will be performed in 36 healthy people between the ages of 18 and 30, who have never taken an antipsychotic, will und...
What is the current status of trial NCT01920802?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 31 participants. The study started on 2012-11. Estimated completion is 2014-09.
What interventions are being tested in trial NCT01920802?
The interventions under investigation include: Placebo (DRUG), iloperidone (DRUG), olanzapine (DRUG).
Who is sponsoring clinical trial NCT01920802?
This trial is sponsored by New York State Psychiatric Institute, which has 364 total clinical trials registered on ClinicalTrials.gov.
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