Health TrialsbyHealthPanel

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

ConditionBipolar Disorder
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-65
SponsorMclean Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Provides informed consent

Between the ages of 18-65

Fluent in English

Meets DSM-5 criteria for bipolar disorder (type I or II)

Disqualifiers

Not fluent in English

Estimated IQ <75

Current substance use disorder, current eating disorder, current or past psychotic disorder (e.g. schizophrenia, schizoaffective disorder)

Endorsement of suicidality

Trial design

Design model

Single group

Treatments tested in this trial

  • Cannabidiol

    Drug

    Custom formulation of a hemp-derived, high-CBD product that contains no THC.

Treatment groups

25 Participants
are divided into 1 treatment group
Group A: Hemp-Derived Cannabidiol SolutionExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Change in self-reported ratings of anxiety on the Beck Anxiety Inventory (BAI)

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).

Time frame
4 weeks

Secondary outcomes

1

Change in self-reported ratings of depression on the Beck Depression Inventory (BDI)

Depressive symptoms will be assessed using the Beck Depression Inventory (BDI), which is a 21-item self-report measure used to rate symptoms of depression on a scale of 0 (none) to 3 (very much). The total score ranges from 0 (no depressive symptoms) to 63 (severe depressive symptoms).

Time frame
4 weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Mclean Hospital

Lead sponsor

Source ClinicalTrials.gov
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