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New treatment option for Bipolar Disorder
Official title Neurofeedback for Bipolar Disorder
ClinicalTrials.gov ID: NCT05802446
What this study is testing
- What it's testing
- Bipolar Disorder (BD) is a severe mood disorder affecting between 1% and 3% of the general population. It is characterized by the succession of depressive and manic episodes, with periods of stabilization during which patients may present "residual" depressive or anxious symptoms, which are characterized by sadness and emotional hyper-reactivity.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 65
You may be able to join if
- 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.
You likely can't join if
- 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...
- Somatic disorder that may affect cognitive abilities and brain structures (e.g., HIV infection, MS, lupus, Parkinson's disease, epilepsy...
- Ongoing non-pharmacological treatment: structured psychotherapeutic interventions (Cognitive Behavioral Therapy - CBT, Interpersonal and Social...
See the full eligibility 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
- 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...
- 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...
- Subject included in clinical and / or therapeutic experimentation in progress.
- Patients under legal protection
- Prisoners
- Pregnancy
- Breastfeeding
The study team makes the final eligibility decision.
Where it's taking place
- Créteil, val-de-marne, France
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 65 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Créteil, val-de-marne, France. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.