Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT05457465 · ClinicalTrials.gov registry record · Phase 2
Assessing the Impact of Cannabidiol for Anxiety and Depression in Bipolar Disorder
A Phase 2 study of Bipolar Disorder, sponsored by Mclean Hospital.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 25
- Enrollment target
- 1
- Study location
NCT05457465: Recruiting Phase 2 study of Bipolar Disorder, sponsored by Mclean Hospital.
NCT05457465 is a Phase 2 study of Bipolar Disorder that is actively recruiting participants, run by Mclean Hospital. The registered enrollment target is 25 participants, below the 333-participant average among 162 other Bipolar Disorder trials with a reported enrollment target (92% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05457465, a Phase 2 study of Bipolar Disorder, is actively recruiting participants, sponsored by Mclean Hospital.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 25 participants
- Enrollment target
- 1
- Study location
Study Summary
Preliminary data have suggested that cannabidiol (CBD) may have a number of clinical benefits, including anti-anxiety and antidepressant properties. This study is a pilot open-label clinical trial assessing a custom-formulated high-CBD product over the course of 4 weeks in patients with bipolar disorder who experience anxiety.
Primary Outcome
Anxiety will be assessed using a number of self-report and administered clinical ratings scales: the primary outcome measure will be the Beck Anxiety Inventory (BAI), which is a 21-item self-report measure used to rate subjective, somatic, and panic-related symptoms of anxiety on a scale of 0 (not at all) to 3 (severely). The total score ranges from 0 (no anxiety) to 63 (severe anxiety).
Conditions Studied
Interventions
- DRUG Cannabidiol
Study Locations (1)
Massachusetts
- McLean Hospital - Belmont
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 25 participants |
| Start Date | 2023-06-01 |
| Est. Completion | 2025-12 |
| Phase | Phase 2 |
What NCT05457465 shows while recruiting
NCT05457465 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 25 participants, a relatively small participant target, below the 333-participant average among 162 other Bipolar Disorder trials with a reported enrollment target (92% lower).
The record links to 1 condition, with Bipolar Disorder appearing as the primary indexed condition, and to 1 intervention - of which Cannabidiol is the first listed.
NCT05457465 reports a single indexed study location in Massachusetts.
Frequently Asked Questions
What is clinical trial NCT05457465 about?
NCT05457465 is a clinical study titled "Assessing the Impact of Cannabidiol for Anxiety and Depression in Bipolar Disorder". Preliminary data have suggested that cannabidiol (CBD) may have a number of clinical benefits, including anti-anxiety and antidepressant properties. This study is a pilot open-label clinical trial assessing a custom-formulated high-CBD product over the course of 4 weeks in patients with bipolar diso...
What is the current status of trial NCT05457465?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 25 participants. The study started on 2023-06-01. Estimated completion is 2025-12.
What conditions does trial NCT05457465 study?
This clinical trial studies the following conditions: Bipolar Disorder.
What interventions are being tested in trial NCT05457465?
The interventions under investigation include: Cannabidiol (DRUG).
Who is sponsoring clinical trial NCT05457465?
This trial is sponsored by Mclean Hospital, which has 140 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05457465 being conducted?
This trial has 1 study location across Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Bipolar Disorder
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05457465's enrollment target sits among peer trials
25 148th of 162 higher than 13 of 162 other Bipolar Disorder trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Bipolar Disorder 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
-
Correcting Circadian Rhythms to Breakthrough in Bipolar Disorder
RECRUITING · Phase 2
-
Gabapentin for Restoring GABA/Glutamate Homeostasis in Co-occurring Bipolar and Cannabis Use Disorders
RECRUITING · Phase 2
-
A Study of Brenipatide in Adult Participants With Bipolar Disorder (RENEW-Bipolar-1)
RECRUITING · Phase 2
-
The Impact of AMPA Receptor Blockade on Ketamine's Anti-Suicidal Effects
RECRUITING · Phase 2
-
BezafibrateTreatment for Bipolar Depression: A Proof of Concept Study
RECRUITING · Phase 2
-
Low Amplitude Pulse Seizure Therapy Versus Standard Ultra-Brief Right Unilateral Electroconvulsive Therapy
RECRUITING · Phase 2
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT01166854 · 25 participants
Characterization of Familial Myopathy and Paget Disease of Bone
- NCT01913106 · 25 participants · Phase 1
HSV-tk + Valacyclovir Therapy in Combination With Brachytherapy for Recurrent Prostate Cancer
- NCT02138669 · 25 participants · NA
Intacs Prescription Inserts for Keratoconus Patients
- NCT02174549 · 25 participants · Phase 1
Dose-defining Study of Tirapazamine Combined With Embolization in Liver Cancer
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI