Validation of a Cognitive Remediation Program for Bipolar Disorders

Centre hospitalier de Ville-Evrard, France1 site in 1 country60 target enrollmentFebruary 2014

ConditionsBipolar Disorder

Overview

Phase: N/A
Intervention: Not specified
Conditions: Bipolar Disorder
Sponsor: Centre hospitalier de Ville-Evrard, France
Enrollment: 60
Locations: 1
Primary Endpoint: Change from baseline Perceptual Reasoning Index at 3 months
Status: Recruiting
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief 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.

Registry

clinicaltrials.gov

Start Date

February 2014

End Date

December 2024

Last Updated

2 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Centre hospitalier de Ville-Evrard, France

Responsible Party

Principal Investigator

Clémence ISAAC

Psychologist

Centre hospitalier de Ville-Evrard, France

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

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

Outcomes

Primary Outcomes

Change from baseline Perceptual Reasoning Index at 3 months

Time Frame: baseline and 3 months

Composite score of the Wechsler Adult Intelligence Scale - fourth edition

Change from 3-months Perceptual Reasoning Index at 9 months

Time Frame: 3 months and 9 months

Composite score of the Wechsler Adult Intelligence Scale - fourth edition

Secondary Outcomes

Emotion Hexagon(baseline, 3 months and 9 months)
Key Search Test(baseline, 3 months and 9 months)
Hamilton Depression Rating Scale(15 days before baseline, 3 months and 9 months)
Young Mania Rating Scale(15 days before baseline, 3 months and 9 months)
Functional Repercussions Scale(baseline, 3 months and 9 months)
Social Desirability Scale(baseline, 3 months and 9 months)
Social Relationships Scale(baseline, 3 months and 9 months)
Self-Appraisal of Illness Questionnaire(baseline, 3 months and 9 months)
Rorschach Inkblot Test(baseline, 3 months and 9 months)
Change from baseline Event-Related Potentials [ERP] P300 at 3 months during an Oddball task(baseline and 3 months)
Change from baseline Event-Related Potentials [ERP] N2/P3 complex at 3 months during an emotional Stroop task(baseline and 3 months)
Change from baseline serum Brain-Derived Neurotrophic Factor [BDNF] level (ng/mL) at 3 months(baseline and 3 months)
Change from baseline functional Magnetic Resonance Imaging frontal activation at 3 months during an emotion recognition task(baseline and 3 months)
Processing Speed Index(baseline, 3 months and 9 months)
Working Memory Index(baseline, 3 months and 9 months)
Cardebat's Verbal Fluencies(baseline, 3 months and 9 months)
Rey Auditory Verbal Learning Test(baseline, 3 months and 9 months)
Stroop Color Word Test(baseline, 3 months and 9 months)