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Cognitive Remediation on Patients With Bipolar Disorder and Memory Complaints (COGMED)

University Hospital Center (CHU) logo

University Hospital Center (CHU)

Status

Unknown

Conditions

Patient With Bipolar Disorder
Euthymic Status
Wirh Memory Complaints

Treatments

Behavioral: COGMED program

Study type

Interventional

Funder types

Other

Identifiers

NCT02988518
UF 9418
2014-A00825-42 (Other Identifier)

Details and patient eligibility

About

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.

Full description

Patients with bipolar disorder and memory complaints will be recruited.

Two visits :

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 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.

Enrollment

41 estimated patients

Sex

All

Ages

18 months to 65 years old

Volunteers

No Healthy Volunteers

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)

Trial design

Primary purpose

Supportive Care

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

41 participants in 1 patient group

COGMED program
Experimental group
Description:
Cognitive remediation using COGMED program on bipolar euthymic patients with memory complaints
Treatment:
Behavioral: COGMED program

Trial contacts and locations

1

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Central trial contact

Emilie OLIE, MD PhD

Data sourced from clinicaltrials.gov

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