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NCT06229977 · ClinicalTrials.gov registry record · Phase 2
A Trial of the Fatty Acid Amide Hydrolase Inhibitor Palmitoylethanolamide in Bipolar Depression
A Phase 2 study, sponsored by The University of Texas Health Science Center, Houston.
- Completed
- Registry status
- Phase 2
- Development phase
- 34
- Enrollment target
NCT06229977: Completed Phase 2 study, sponsored by The University of Texas Health Science Center, Houston.
NCT06229977 is a Phase 2 study that has completed, run by The University of Texas Health Science Center, Houston. The registered enrollment target is 34 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (74% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06229977, a Phase 2 study, has completed, sponsored by The University of Texas Health Science Center, Houston.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 34 participants
- Enrollment target
Study Summary
The purpose of this study is to o evaluate the antidepressant efficacy of the PEA in Bipolar Depression and the association between antidepressant response with endogenous cannabinoids and cytokine levels
Primary Outcome
The Hamilton Depression Rating Scale measures severity of depression. The total score ranges from 0 to 26, higher score indicating greater depression severity. The change in score will be reported. The change in score will be reported as the \[(Score at 6 weeks follow up) - (Score at Baseline)\] - A negative value indicates improvement of depression severity.
Interventions
- DRUG Placebo
- DRUG Palmitoylethanolamide (PEA)
- DRUG Treatment as Usual (TAU)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 34 participants |
| Start Date | 2023-05-17 |
| Est. Completion | 2025-07-17 |
| Phase | Phase 2 |
What the finished NCT06229977 record still lists
NCT06229977 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 34 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (74% lower).
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT06229977 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT06229977 about?
NCT06229977 is a clinical study titled "A Trial of the Fatty Acid Amide Hydrolase Inhibitor Palmitoylethanolamide in Bipolar Depression". The purpose of this study is to o evaluate the antidepressant efficacy of the PEA in Bipolar Depression and the association between antidepressant response with endogenous cannabinoids and cytokine levels
What is the current status of trial NCT06229977?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 34 participants. The study started on 2023-05-17. Estimated completion is 2025-07-17.
What interventions are being tested in trial NCT06229977?
The interventions under investigation include: Placebo (DRUG), Palmitoylethanolamide (PEA) (DRUG), Treatment as Usual (TAU) (DRUG).
Who is sponsoring clinical trial NCT06229977?
This trial is sponsored by The University of Texas Health Science Center, Houston, which has 732 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT06229977's enrollment target sits among peer trials
34 1539th of 2000 higher than 448 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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