Phase 2 Bipolar Disorder Trial, Recruiting NCT05457465 Sponsor: Mclean Hospital Condition: Bipolar Disorder
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Phase 2 Bipolar Disorder Trial, Recruiting

NCT05457465
Recruiting Phase 2

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • People who are willing and able to give their informed consent to participate
  • People aged between 18 and 65 years old
  • People who are fluent in English
  • People who have been diagnosed with bipolar disorder (type I or type II) according to standard diagnostic guidelines
  • People who experience at least moderate levels of anxiety, based on self-reported rating scales
  • People who are on a stable medication routine that has not recently changed

Who may not be able to join:

  • People who are not fluent in English
  • People whose estimated IQ is below 75
  • People who currently have a substance use disorder, an eating disorder, or who have a current or past diagnosis of a psychotic disorder (such as schizophrenia or schizoaffective disorder)
  • People who are currently experiencing thoughts of suicide
  • People who are currently going through an acute manic episode
  • People who are currently going through an acute depressive episode
  • People who have had a head injury or lost consciousness for more than 5 minutes at any point in their life
  • People who currently use cannabis or cannabinoid products on a regular basis
  • People who are pregnant or breastfeeding
  • People who have a serious medical illness or a neurological condition
  • People who have an allergy to palm oil
  • People who are currently taking the medications valproate or divalproex, or certain other medications (assessed case by case by the trial site)
  • People who are currently enrolled in another clinical trial that involves a treatment
  • People whose liver function test results are elevated at the screening visit (confirm with trial site)

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 27 July 2026
Phase 2: approximately ~30% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.
Phase success rates shown are historical industry-wide averages based on published data. They are not a prediction for this specific trial or your individual situation.

Contact this trial

Phone: 617-855-3338

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Phase 2
Sponsor
Mclean Hospital
Registry
ClinicalTrials.gov
Start date
1 June 2023
Est. completion
1 December 2026

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

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

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 27 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov