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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: Completed Phase 1 study, sponsored by Mclean Hospital.
NCT00567034 is a Phase 1 study that has completed, run by Mclean Hospital. The registered enrollment target is 30 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (50% lower). According to ClinicalTrials.gov, the official US trial registry.
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 |
What the finished NCT00567034 record still lists
NCT00567034 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 30 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (50% lower).
The record links to 0 conditions, and to 2 interventions - of which placebo is the first listed.
NCT00567034 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00567034's enrollment target sits among peer trials
30 1332nd of 2000 higher than 561 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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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