Bipolar Disorder Trial, Recruiting (NCT06365021)

Bipolar Disorder Trial, Recruiting NCT06365021 Sponsor: Beny Lafer Condition: Bipolar Disorder

Printed from Voxsanity (voxsanity.com.au) — NCT06365021 — Data sourced from ClinicalTrials.gov. Verify directly with the trial site before attending. Not medical advice.

Back to Bipolar Disorder

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 have been diagnosed with Bipolar Disorder type I or type II, as defined by the DSM-5 (a standard medical guide used to classify mental health conditions)
People who are currently experiencing depressive symptoms, based on a score above 12 on a standard depression rating scale (MADRS)
People who are not currently receiving any form of psychotherapy (talking therapy)
People who are able to attend group therapy sessions in person
People who are willing and able to sign a consent form agreeing to take part

Who may not be able to join:

People who have a mental disorder caused by a physical or biological condition affecting the brain (sometimes called an organic mental disorder)
People who are currently experiencing manic or hypomanic symptoms, based on a score above 12 on a standard rating scale (YMRS)
People who are currently in psychotherapy and are not able to pause it for the duration of the study
People who have had a significant change to their psychiatric medication within the last 30 days

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

This study is not part of the standard drug-approval phase pathway (for example an observational, device, behavioural, or registry study), so a phase success rate does not apply.

Contact this trial

Principal Investigator: Beny Lafer, MD PhD, University of Sao Paulo

Phone: +5511 999381849

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.

Voxsanity

Clinical trials and treatments, explained plainly · voxsanity.com.au

Date:

To: My Doctor

Re: Clinical trial enquiry

I am writing to enquire about the following clinical trial which may be relevant to my care:

Trial: NCT06365021

Sponsor: Beny Lafer

Phase: Not Applicable

Status: Recruiting

Condition: Bipolar Disorder

Trial contact: +5511 999381849

More information: https://clinicaltrials.gov/study/NCT06365021

Eligibility summary (AI generated)

Written by an AI model from ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

People who have been diagnosed with Bipolar Disorder type I or type II, as defined by the DSM-5 (a standard medical guide used to classify mental health conditions)
People who are currently experiencing depressive symptoms, based on a score above 12 on a standard depression rating scale (MADRS)
People who are not currently receiving any form of psychotherapy (talking therapy)
People who are able to attend group therapy sessions in person
People who are willing and able to sign a consent form agreeing to take part

Who may not be able to join:

People who have a mental disorder caused by a physical or biological condition affecting the brain (sometimes called an organic mental disorder)
People who are currently experiencing manic or hypomanic symptoms, based on a score above 12 on a standard rating scale (YMRS)
People who are currently in psychotherapy and are not able to pause it for the duration of the study
People who have had a significant change to their psychiatric medication within the last 30 days

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

Access in Australia: A treatment being studied in a clinical trial is generally not yet listed on the PBS. Where a medicine is not approved or not available through a trial, the TGA Special Access Scheme may allow a doctor to access unapproved therapeutic goods for individual patients. See voxsanity.com.au/sas-navigator/ for a plain English explainer.

This information was sourced from ClinicalTrials.gov via Voxsanity (data last synced 27 July 2026). It is not medical advice. Please verify the trial's current status directly with the trial site before acting.

Trial details

Status

Recruiting

Phase

Not Applicable

Sponsor

Beny Lafer

Registry

ClinicalTrials.gov

Start date

6 May 2024

Est. completion

1 December 2025

Where this trial is recruiting

🇧🇷 Brazil

Primary endpoints

Montgomery-Asberg Depression Scale; Young Mania Rating Scale

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