Real-time fMRI Neurofeedback to Reduce Residual Symptoms in Bipolar Disorder

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This interventional trial uses real-time functional MRI neurofeedback to train adults with bipolar I or II to self-regulate brain activity linked to emotion, aiming to reduce residual depressive or anxiety symptoms. Eligible participants are aged 18–65, have been free of a major mood episode for at least three months, have low but persistent depressive symptoms, and are on a stable dose of mood stabilizer. The intervention consists of fMRI neurofeedback sessions with MRI safety screening and exclusion of major comorbid psychiatric disorders or substance abuse (except tobacco/cannabis). Outcomes will include changes on standard symptom scales (e.g., MADRS, YMRS) and measures of daily functioning.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Patients diagnosed with bipolar disorder I or II (DSM-5 criteria);
* Aged between ≥ 18 and ≤ 65;
* Absence of major mood episode for at least 3 months before inclusion (MADRS scores \< 12; YMRS score \< 10);
* Presence of residual depressive symptoms, as assessed by the MADRS (score \> 5);
* Stabilized dose of mood stabilizer medication for at least 3 months before inclusion.
* Written consent
* Affiliation to a social security system
* Effective contraception for women of childbearing age

Exclusion Criteria:

* Severe physical disorders that may be life-threatening;
* Major psychiatric (Axis 1) comorbidities except for anxiety disorders;
* Any current substance abuse except for tobacco or cannabis. Substance abuse will be defined by the DSM V criteria;
* Exclusion criteria applicable to MRI Panic disorder, claustrophobia, epilepsy Pace maker or neuronal stimulator, intraocular or intracerebral metallic foreign body, cochlear implant, cardiac valve or metallic surgical arterial material, non removable removable magnetizable metallic material
* Somatic disorder that may affect cognitive abilities and brain structures (e.g., HIV infection, MS, lupus, Parkinson's disease, epilepsy, dementia...);
* Ongoing non-pharmacological treatment: structured psychotherapeutic interventions (Cognitive Behavioral Therapy - CBT, Interpersonal and Social Rhythm Therapy - IPSRT) as well as brain stimulation techniques (Electroconvulsive Therapy - ECT, Transcranial Magnetic Stimulation - TMS, Deep Brain Stimulation - DBS);
* Subject included in clinical and / or therapeutic experimentation in progress.
* Patients under legal protection
* Prisoners
* Pregnancy
* Breastfeeding

Where it's running

• Albert Chenevier
  Créteil, val-de-marne, France Recruiting

Study contacts

• Study coordinator: Josselin HOUENOU, Professor (MD, PhD)
• Email: josselin.houenou@aphp.fr
• Phone: (+33)1 49 81 30 51

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.