Evaluation of a Cognitive Remediation Program for Mood Disorders

Taking Charge of Cognitive Impairment in Patients With Mood Disorders Clinical Trial

— ECO-DBP  

Official title:

Evaluation of a Cognitive Remediation Program for Mood Disorders

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04354974
• Other study ID #: 10477M-ECO-DBP-2019
• Status: Recruiting
• Phase: N/A
• Start date: October 18, 2019
• Est. completion date: February 18, 2023

Study information

• Verified date: July 2020
• Source: Centre hospitalier de Ville-Evrard, France
• Contact: Youcef BENCHERIF
• Phone: 0782723674
• Email: youcef.bencherif[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Psychotherapeutic management of cognitive disorders in patients suffering from a mood disorder

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 36
• Est. completion date: February 18, 2023
• Est. primary completion date: February 18, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

1. Age between 18 and 65 years old

2. The patient's previous diagnosis of Bipolar-Related Disorder or Depressive Disorder according to the DSM-5 criteria.

3. Mood stabilized with respect to depressive symptomatology (absence or presence of residual mild depressive symptoms (HDRS-17 = 18))

4. Mood stabilized with respect to manic symptomatology (absence or presence of residual mild manic symptoms (YMRS = 8))

5. Stable and effective treatment at minimum dose for at least 2 months

6. Cognitive complaint expressed by the patient, and detected by the patient's referring psychiatrist

7. Free and Informed Consent Form read, initialled and signed

8. Patient affiliated to a social protection scheme or beneficiary of State Medical Aid

9. Patient knowing how to speak French -

Exclusion Criteria:

1. Presence of a DSM-5 disorder, other than a mood, anxiety or personality disorder

2. Substance addiction or abuse (Alcohol, psychoactive substances) in the past 12 months

3. Manic, hypomanic or major depressive episode in the last 2 months

4. Somatic or neurological disorder which may lead to cognitive impairment

5. Current or less than one month's commitment to another research protocol

6. A neuropsychological assessment prior to 6 months.

7. Patient under protective custody, guardianship or reinforced guardianship

Related Conditions & MeSH terms

• Mood Disorders
• Taking Charge of Cognitive Impairment in Patients With Mood Disorders

Intervention

Behavioral:
• Evaluation
Evaluation of a cognitive remediation program for mood disorders

Locations

Country	Name	City	State
France	Youcef Bencherif	Neuilly sur Marne

Sponsors (1)

Lead Sponsor	Collaborator
Centre hospitalier de Ville-Evrard, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the Perceptual Reasoning Index (PRI) the Wechsler Intelligence Scale.	Increase in the Perceptual Reasoning Index (PRI) of the Wechsler Adult Intelligence Scale - Fourth Edition [WAIS-IV] significantly different between the two study groups.	at 1 year