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NCT03831854 · ClinicalTrials.gov registry record · Phase 3
Lamotrigine in Reducing Psychologic Side-Effect of Perioperative Ketamine
A Phase 3 study, sponsored by The Cleveland Clinic.
- Completed
- Registry status
- Phase 3
- Development phase
- 46
- Enrollment target
NCT03831854: Completed Phase 3 study, sponsored by The Cleveland Clinic.
NCT03831854 is a Phase 3 study that has completed, run by The Cleveland Clinic. The registered enrollment target is 46 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (94% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03831854, a Phase 3 study, has completed, sponsored by The Cleveland Clinic.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 46 participants
- Enrollment target
Study Summary
Patient will receive lamotrigine vs. placebo with small sips of water. Lamotrigine reaches peak level 1-4 hours after oral administration.
Primary Outcome
The primary outcome of psychologic side-effects was measured in PACU (up to 90 minutes after ketamine infusion). This included four key items of the Brief Psychiatric Rating Scale (BPRS) corresponding to positive symptoms of schizophrenia: conceptual disorganization, hallucinatory behavior, suspiciousness, and unusual thought content. Each symptom is rated 1-7 ( 1 = not present, 2 = very mild, 3 = mild, 4 = moderate, 5 = moderately severe, 6 = severe, 7 = extremely severe ), and, therefore, the
Interventions
- DRUG Placebo
- DRUG Ketamine
- DRUG Lamotrigine 300 MG
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 46 participants |
| Start Date | 2019-01-24 |
| Est. Completion | 2020-12-31 |
| Phase | Phase 3 |
What the finished NCT03831854 record still lists
NCT03831854 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 46 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (94% lower).
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT03831854 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03831854 about?
NCT03831854 is a clinical study titled "Lamotrigine in Reducing Psychologic Side-Effect of Perioperative Ketamine". Patient will receive lamotrigine vs. placebo with small sips of water. Lamotrigine reaches peak level 1-4 hours after oral administration.
What is the current status of trial NCT03831854?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 46 participants. The study started on 2019-01-24. Estimated completion is 2020-12-31.
What interventions are being tested in trial NCT03831854?
The interventions under investigation include: Placebo (DRUG), Ketamine (DRUG), Lamotrigine 300 MG (DRUG).
Who is sponsoring clinical trial NCT03831854?
This trial is sponsored by The Cleveland Clinic, which has 688 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03831854's enrollment target sits among peer trials
46 1868th of 2000 higher than 131 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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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