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NCT00567034 · ClinicalTrials.gov registry record · Phase 1
Augmenting Zyprexa With Naltrexone to Ameliorate Metabolic Side-Effects
A Phase 1 study, sponsored by Mclean Hospital.
- Completed
- Registry status
- Phase 1
- Development phase
- 30
- Enrollment target
NCT00567034 is a Phase 1 study that has completed, run by Mclean Hospital. The registered enrollment target is 30 participants.
The verdict
NCT00567034, a Phase 1 study, has completed, sponsored by Mclean Hospital.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 30 participants
- Enrollment target
Study Summary
The main purpose of this study is to determine whether the opioid antagonist naltrexone is helpful in ameliorating the weight gain and other adverse metabolic side effects experienced by schizophrenic patients taking the second generation antipsychotic (SGA) Zyprexa. Schizophrenics may have an altered/enhanced endogenous opioidergic drive, and because of this, normally painful stimuli will be sensed as less painful in schizophrenics vs. healthy controls. A secondary hypothesis for this study is that naltrexone augmentation of Zyprexa will normalize subjective pain ratings. Our tertiary objective is to examine the safety and tolerability of naltrexone in Zyprexa-treated patients with schizophrenia.
Interventions
- DRUG placebo
- DRUG naltrexone
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2006-12 |
| Est. Completion | 2011-12 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00567034
The ClinicalTrials.gov registry entry for NCT00567034 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 30 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Mclean Hospital, which has 140 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which placebo is the first listed.
NCT00567034 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00567034 about?
NCT00567034 is a clinical study titled "Augmenting Zyprexa With Naltrexone to Ameliorate Metabolic Side-Effects". The main purpose of this study is to determine whether the opioid antagonist naltrexone is helpful in ameliorating the weight gain and other adverse metabolic side effects experienced by schizophrenic patients taking the second generation antipsychotic (SGA) Zyprexa. Schizophrenics may have an alter...
What is the current status of trial NCT00567034?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 30 participants. The study started on 2006-12. Estimated completion is 2011-12.
What interventions are being tested in trial NCT00567034?
The interventions under investigation include: placebo (DRUG), naltrexone (DRUG).
Who is sponsoring clinical trial NCT00567034?
This trial is sponsored by Mclean Hospital, which has 140 total clinical trials registered on ClinicalTrials.gov.
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