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NCT02708394
Molecular Mechanisms of Antipsychotic-induced Insulin Resistance
EARLY_PHASE1 trial testing olanzapine in Adverse Effect of Other Antipsychotics and Neuroleptics in 31 participants. Completed in 1 October 2023.
1 October 2023
Quick facts
| Lead sponsor | Wayne State University |
|---|---|
| Phase | EARLY_PHASE1 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | triple |
| Primary purpose | other |
| Enrollment | 31 |
| Start date | 1 February 2017 |
| Primary completion | 1 October 2023 |
| Estimated completion | 1 October 2023 |
| Sites | 1 location across United States |
Drugs / interventions tested
- olanzapine (olanzapine) — full drug profile →
- placebo
Conditions studied
- Adverse Effect of Other Antipsychotics and Neuroleptics — all drugs for Adverse Effect of Other Antipsychotics and Neuroleptics →
- Insulin Resistance — all drugs for Insulin Resistance →
Sponsor
Wayne State University
Who can join
Adults 21 to 45, any sex, with Adverse Effect of Other Antipsychotics and Neuroleptics or Insulin Resistance. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This study will investigate the molecular mechanisms of atypical-antipsychotic induced insulin resistance. This will be accomplished by administering olanzapine or placebo to healthy subjects for 7 days and analyzing genetic and protein changes in peripheral tissues known to play an important role in insulin resistance pathophysiology.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
Alterations in Skeletal Muscle Insulin Signaling DNA Methylation: A Pilot Randomized Controlled Trial of Olanzapine in Healthy Volunteers.
Burghardt KJ, Burghardt PR, Howlett BH, Dass SE, et al · · 2024 · cited 3× · PMID 38791018 · DOI 10.3390/biomedicines12051057
Verify or expand the search:
- PubMed search for NCT02708394
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of olanzapine
Trials testing the same drug.
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- NCT06600477 — A Study of Olanzapine After Intranasal and Intramuscular Administration · Phase 1 · completed
- NCT03557931 — A Study to Assess the Safety and Efficacy of ASP4345 as Add-on Treatment for Cognitive Impairment in Subjects With Schiz · Phase 2 · completed
- NCT00149292 — Study of LY2140023 in Schizophrenia Comparing LY2140023, Olanzapine, and Placebo · Phase 2 · completed
- NCT00156117 — Efficacy and Safety of Asenapine With Placebo and Olanzapine (41021)(P05933) · Phase 3 · completed
Other Wayne State University trials
Trials by the same sponsor.
- NCT07219394 — Peer-Delivered Behavioral Activation in a CCBHC · NA · recruiting
- NCT07123467 — Cannabidiol-Assisted Learning for Managing Generalized Anxiety Disorder · Phase 3 · recruiting
- NCT07222306 — Cannabis, Neuroinflammation, and Suicidal Ideation: A Supplemental Brain Imaging Study · enrolling by invitation
- NCT05684978 — Efficacy and Safety of Perampanel in the Treatment of Refractory Status Epilepticus · Phase 4 · terminated
- NCT06381180 — Warrior CARE: Cannabis Behavioral Health · Phase 1, PHASE2 · not yet recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT02708394 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Wayne State University
- Last refreshed: 31 October 2023
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02708394.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing