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Assessing the Impact of Cannabidiol for Anxiety and Depression in Bipolar Disorder

StatusRecruiting
PhasePhase 2
Started2023-06-01
View on ClinicalTrials.gov ↗

Amendment history

2026-03-24
Study Status, Oversight v5
Primary completion date2025-12→2026-12
Completion date2025-12→2026-12
2025-03-14
Study Status, Oversight, Eligibility v4
Primary completion date2025-06→2025-12
Completion date2025-06→2025-12
Eligibility criteria-4 characters
Inclusion Criteria: Provides informed consent Between the ages of 18-5565 Fluent in English Meets DSM-5 criteria for bipolar disorder [...] ls of anxiety (as evidenced by self-reported rating scales) Is not currently experiencing greater than moderate levels of depression (evidenced by administered rating scales) On a stable pharmacotherapeutic regimen Exclusion Criteria: Not fluent in English Estimated IQ <75 Current or past substance use disorder or psychotic disorder;, current eating disorder, current or past psychotic disorder (e.g. schizophrenia, schizoaffective disorder) Endorsement of suicidal [...] [...]
2024-03-07
Study Status v3
Re-verified, no change to tracked fields
2023-08-30
Not Yet Recruiting→Recruiting Study Status, Eligibility, Contacts/Locations v2
Trial statusNot Yet Recruiting→Recruiting
Primary completion date2025-07→2025-06
Completion date2025-07→2025-06
Start dateestimated 2023-07→confirmed 2023-06-01
Study sites0→1
Eligibility criteriarevised
Inclusion Criteria: Provides informed consent Between the ages of 18-55 Fluent in English Meets DSM-V5 criteria for bipolar disorder (type I or II) Experiences at [...]
2023-03-13
Study Status v1
Primary completion date2024-07→2025-07
Completion date2024-07→2025-07
Start date2022-08→2023-07
2022-07-11
Original filing
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.
Trial Details
NCT Number NCT05457465
Lead Sponsor Mclean Hospital
Conditions Bipolar Disorder
Enrollment 25 participants
Start Date 2023-06-01
Primary Completion 2026-12 (estimated)
Study Completion 2026-12 (estimated)
Updated on ClinicalTrials.gov 2026-03-30