Cognitive Remediation on Patients With Bipolar Disorder and Memory Complaints

Euthymic Status Clinical Trial

— COGMED  

Official title:

Evaluation of a Cognitive Remediation Program on Patients With Bipolar Disorders, With Memory Complaints

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02988518
• Other study ID #: UF 9418
• Secondary ID: 2014-A00825-42
• Status: Recruiting
• Phase: N/A
• First received: August 1, 2016
• Last updated: December 6, 2016
• Start date: July 2014
• Est. completion date: November 2017

Study information

• Verified date: July 2016
• Source: University Hospital, Montpellier
• Contact: Emilie OLIE, MD PhD
• Phone: +33 4 67 33 85 81
• Email: e-olie[@]chu-montpellier.fr
• Is FDA regulated: No
• Health authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé
• Study type: Interventional

Clinical Trial Summary

Bipolar disorder is a major health concern. Intercritical periods are marked with residual symptoms, both thymic and cognitive, which affects quality of life of patients, but also the quality of observance. The implementation of cognitive remediation programs could be interesting. The aim of this study is to evaluate the overall performance on euthymic bipolar patients with memory complaints included in the program named "COGMED", targeting the working memory.

The impact of this program on compliance, quality of life, and memory complaints will be evaluated.

The investigator will measure whether there is a correlation between working memory and overall performances.

Finally, the investigator will try to achieve a profile of bipolar patients in whom the Cogmed program is particularly effective on a plan of overall performance.

Description:

Patients with bipolar disorder and memory complaints will be recruited.

Two visits :

1. at baseline (V0) : the investigator evaluate bipolar disorder, treatment, mood, quality of life, global functioning, and memory complaints. Patients also have a neuropsychological assessment. The COGMED program is proposed to patients with memory complaints and explain by the investigator

2. 4-6 weeks after the end of the program (11-13 weeks after V1) : the same evaluation is realized to compare score before and after the program of cognitive remediation.

Between the two visits the patient will benefit of COGMED program, at home, during 5 weeks.

COGMED is a remediation cognitive program, based on working memory, consisting on daily exercises at home on a computer.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 41
• Est. completion date: November 2017
• Est. primary completion date: November 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Months to 65 Years

Eligibility

Inclusion criteria:

• Being diagnosed bipolar according to the Diagnostic and Statistical Manual of Mental Disorders - IV (DSM-IV) criteria

• Memory complaints or overall performance alterations according to the memory scale (MEM III Wechsler memory scale - third edition)

• Being euthymic at the inclusion according to Montgomery-Asberg Depression Rating Scale (MADRS < 12) and Young Mania Rating Scale (YMRS < 6)

• Not being treated with electroconvulsive therapy for the last year

• Not having drug-dependance or drug-abuse for the last six months

• Having a computer with internet and a cellphone at home

• Having signed informed consent

• Able to understand nature, aims and methodology of the study

Exclusion criteria:

• Patient on protective measures (guardianship or trusteeship)

• Deprived of liberty subject (judicial or administrative decision)

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Bipolar Disorder
• Disease
• Euthymic Status
• Patient With Bipolar Disorder
• Wirh Memory Complaints

Intervention

Behavioral:
• COGMED program
Patient should connect on his computer at home, 5 times a week, for 5 weeks. Every day, the patient has to do 8 exercises for a total duration of 30 to 45 minutes. In total, the patient will have to complete 25 sessions. The difficulty level of the proposed items adjust automatically to the patient's maximum capacity to compel him to provide a cognitive effort. A progression index assesses the progress made by the patient. Every week, the investigator will call the patient for 10 minutes in order to gather the patient's feelings, his difficulties, provide some advice and encourage him. The investigator will have to analyze the results of curves available for each event, as well as the patient's progress index.

Locations

Country	Name	City	State
France	Montpellier University Hospital	Montpellier

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Montpellier

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evolution of the global functioning between the inclusion and the end of the program	evaluation of variation of global functioning will be realized by the Functioning Assessment Short Test (FAST) scale after COGMED program.	At 4 weeks	No
Primary	Evolution of the global functioning between the inclusion and the end of the program	evaluation of variation of global functioning will be realized by the Functioning Assessment Short Test (FAST) scale after COGMED program	At 6 weeks	No
Secondary	Observance	Evaluation of variation of patient's compliance by Medication Adherence Rating Scale (MARS) score after COGMED program.	At the inclusion and 4 to 6 weeks until the end of the program COGMED (11 to 13 weeks after inclusion)	No
Secondary	Quality of life	Evaluation of variation of quality of life by Short Form (36) Health Survey (SF-36) score after COGMED program.	At the inclusion and 4 to 6 weeks until the end of the program COGMED (11 to 13 weeks after inclusion)	No
Secondary	Correlation between working memory and global functioning	Searching a statistical correlation between global functioning (using FAST) and working memory (using neuropsychological tests)	At the inclusion and 4 to 6 weeks until the end of the program COGMED (11 to 13 weeks after inclusion)	No
Secondary	Memory complaints	Variations on memory complaints will be evaluated by Mac Nair Scale score before and after COGMED program.	At the inclusion and 4 to 6 weeks until the end of the program COGMED (11 to 13 weeks after inclusion)	No