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NCT02447835 · ClinicalTrials.gov registry record · Phase 1
Effect of Short Term Atypical Antipsychotic Administration Compared to Placebo on Hepatic Insulin Extraction
A Phase 1 study of Normal Non-fluency, sponsored by Michael Rickels.
- Completed
- Registry status
- Phase 1
- Development phase
- 15
- Enrollment target
- 1
- Study location
NCT02447835: Completed Phase 1 study of Normal Non-fluency, sponsored by Michael Rickels.
NCT02447835 is a Phase 1 study of Normal Non-fluency that has completed, run by Michael Rickels. The registered enrollment target is 15 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (75% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02447835, a Phase 1 study of Normal Non-fluency, has completed, sponsored by Michael Rickels.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 15 participants
- Enrollment target
- 1
- Study location
Study Summary
Within the past 20 years, there has been a striking increase in the incidence of obesity 1;2, type 2 diabetes mellitus (T2DM) 3-5, and cardiovascular diseases (CVD) in the schizophrenic population 6-8 . Large NIH-funded trials indicate that the prevalence of metabolic syndrome is twice to three times greater in schizophrenic patients on a specific class of drug termed the "atypical antipsychotics" (AAPs), of which olanzapine is an example, as compared to matched controls 8. Identification of the pathophysiological mechanisms contributing to metabolic disease in schizophrenic patients on AAPs has been hampered by the inability to differentiate underlying disease from treatment-emergent complications. In addition, despite falling within the same drug class, different AAPs exhibit differential associations with metabolic disease. Olanzapine is one of the AAPs associated with the greatest weight gain and degree of metabolic impairments.
Conditions Studied
Interventions
- DRUG Olanzapine
Study Locations (1)
Pennsylvania
- University of Pennsylvania - Philadelphia
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 15 participants |
| Start Date | 2012-08 |
| Est. Completion | 2014-12 |
| Phase | Phase 1 |
What the finished NCT02447835 record still lists
NCT02447835 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 15 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (75% lower).
The record links to 1 condition, with Normal Non-fluency appearing as the primary indexed condition, and to 1 intervention - of which Olanzapine is the first listed.
NCT02447835 reports a single indexed study location in Pennsylvania.
Frequently Asked Questions
What is clinical trial NCT02447835 about?
NCT02447835 is a clinical study titled "Effect of Short Term Atypical Antipsychotic Administration Compared to Placebo on Hepatic Insulin Extraction". Within the past 20 years, there has been a striking increase in the incidence of obesity 1;2, type 2 diabetes mellitus (T2DM) 3-5, and cardiovascular diseases (CVD) in the schizophrenic population 6-8 . Large NIH-funded trials indicate that the prevalence of metabolic syndrome is twice to three time...
What is the current status of trial NCT02447835?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 15 participants. The study started on 2012-08. Estimated completion is 2014-12.
What conditions does trial NCT02447835 study?
This clinical trial studies the following conditions: Normal Non-fluency.
What interventions are being tested in trial NCT02447835?
The interventions under investigation include: Olanzapine (DRUG).
Who is sponsoring clinical trial NCT02447835?
This trial is sponsored by Michael Rickels, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02447835 being conducted?
This trial has 1 study location across Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02447835's enrollment target sits among peer trials
15 1798th of 2000 higher than 157 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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