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Validation of a Cognitive Remediation Program for Bipolar Disorders | Clinical Trials | Clareo Health

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Validation of a Cognitive Remediation Program for Bipolar Disorders

NCT02698696•Centre hospitalier de Ville-Evrard, France

Summary

This study evaluates the effect of a new cognitive remediation program designed for patients suffering from a bipolar disorder, on cognitive functions, psychosocial functioning and neural processes. In this double-blind (patient, outcomes assessor) controlled randomized trial the investigators compare patients receiving the ECo program for bipolar disorders, to patients benefiting from the broadly used cognitive remediation program CRT and to patients receiving supportive psychotherapy. Patients are treated for 3 months and monitored for 9 months.

Eligibility

Age

18 - 60 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Type I or type II Bipolar Disorder diagnosis, according to DSM-IV-TR criteria
•2. No Manic or Major Depressive episode during the last three months
•3. No or few residual depressive symptoms (HDRS-17 ≤ 12)
•4. No or few residual manic symptoms (YMRS ≤ 8)
•5. Stable dose of medication for the last two months
•6. Cognitive complaint expressed by the patient and impairment observed by the patient's regular psychiatrist
•7. Informed consent form read, initialed and signed
•8. Patient registered on the social welfare system

Exclusion Criteria

•1. Other diagnosis than Bipolar Disorder on axis I of the DSM-IV-TR
•2. Rapid Cycling Bipolar Disorder diagnosis
•3. Addiction or substance abuse (except tobacco) during the twelve last months
•4. Physical or neurological disorder that can lead to cognitive impairment
•5. Engagement in a research protocol either currently or over the last month
•6. Neuropsychological assessment or Rorschach Inkblot Test evaluation during the last six months
•7. Ineligibility for Magnetic Resonance Imaging \[MRI\] (e.g. claustrophobia, metallic implants, pace-maker, etc.)

Locations (1)

Unité de Recherche Clinique, EPS Ville Evrard

Neuilly-sur-Marne, France

Key Dates

Start Date

February 1, 2014

Primary Completion Date

December 1, 2024

Completion Date

December 1, 2024

Last Updated

February 8, 2024

Enrollment

ESTIMATED participants

Conditions

Bipolar Disorder

Interventions

ECo program

OTHER

CRT program

OTHER

Supportive psychotherapy

OTHER

Contacts

Clémence Isaac, Psychologist

CONTACT

0033143093232 clm.isaac@gmail.com

Dominique Januel, MD Phd

CONTACT

0033143093424 domjanuel@gmail.com

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Treatment Resistant DepressionMajor Depressive Episode+5 more

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RECRUITINGPHASE3

A Study to Evaluate the Efficacy and Safety of Adjunctive KarXT for the Treatment of Mania, With or Without Mixed Features, in Participants With Bipolar-I Disorder Taking Lithium, Valproate, or Lamotrigine

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ManiaBipolar Disorder

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 8, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Validation of a Cognitive Remediation Program for Bipolar Disorders

Inclusion Criteria

Exclusion Criteria

University of Iowa Interventional Psychiatry Service Patient Registry

A Study to Evaluate the Efficacy and Safety of Adjunctive KarXT for the Treatment of Mania, With or Without Mixed Features, in Participants With Bipolar-I Disorder Taking Lithium, Valproate, or Lamotrigine

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