Validation of a Cognitive Remediation Program for Bipolar Disorders

Last updated: February 7, 2024
Sponsor: Centre hospitalier de Ville-Evrard, France
Overall Status: Active - Recruiting

Phase

N/A

Condition

Bipolar Disorder

Mood Disorders

Treatment

ECo program

Supportive psychotherapy

CRT program

Clinical Study ID

NCT02698696
10477M
  • Ages 18-60
  • All Genders

Study 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 Criteria

Inclusion

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'sregular psychiatrist
  7. Informed consent form read, initialed and signed
  8. Patient registered on the social welfare system

Exclusion

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 sixmonths
  7. Ineligibility for Magnetic Resonance Imaging [MRI] (e.g. claustrophobia, metallicimplants, pace-maker, etc.)

Study Design

Total Participants: 60
Treatment Group(s): 3
Primary Treatment: ECo program
Phase:
Study Start date:
February 01, 2014
Estimated Completion Date:
December 31, 2024

Connect with a study center

  • Unité de Recherche Clinique, EPS Ville Evrard

    Neuilly-sur-Marne, 93332
    France

    Active - Recruiting

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