Validation of a Cognitive Remediation Program for Bipolar Disorders

Bipolar Disorder Clinical Trial

— ECO-BIP  

Official title:

Validation of a Cognitive Remediation Program for Bipolar Disorders

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02698696
• Other study ID #: 10477M
• Status: Recruiting
• Phase: N/A
• Start date: February 2014
• Est. completion date: December 2024

Study information

• Verified date: February 2024
• Source: Centre hospitalier de Ville-Evrard, France
• Contact: Clémence Isaac, Psychologist
• Phone: 0033143093232
• Email: clm.isaac[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: December 2024
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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's regular psychiatrist

7. Informed consent form read, initialed and signed

8. Patient registered on the social welfare system

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 six months

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

Related Conditions & MeSH terms

• Bipolar Disorder

Intervention

Other:
• ECo program

• CRT program

• Supportive psychotherapy

Locations

Country	Name	City	State
France	Unité de Recherche Clinique, EPS Ville Evrard	Neuilly-sur-Marne

Sponsors (1)

Lead Sponsor	Collaborator
Centre hospitalier de Ville-Evrard, France

Country where clinical trial is conducted

France, 

References & Publications (3)

Altshuler LL, Ventura J, van Gorp WG, Green MF, Theberge DC, Mintz J. Neurocognitive function in clinically stable men with bipolar I disorder or schizophrenia and normal control subjects. Biol Psychiatry. 2004 Oct 15;56(8):560-9. doi: 10.1016/j.biopsych.2004.08.002. — View Citation

Deckersbach T, Nierenberg AA, Kessler R, Lund HG, Ametrano RM, Sachs G, Rauch SL, Dougherty D. RESEARCH: Cognitive rehabilitation for bipolar disorder: An open trial for employed patients with residual depressive symptoms. CNS Neurosci Ther. 2010 Oct;16(5 — View Citation

Martinez-Aran A, Torrent C, Sole B, Bonnin CM, Rosa AR, Sanchez-Moreno J, Vieta E. Functional remediation for bipolar disorder. Clin Pract Epidemiol Ment Health. 2011;7:112-6. doi: 10.2174/1745017901107010112. Epub 2011 Jun 6. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline Perceptual Reasoning Index at 3 months	Composite score of the Wechsler Adult Intelligence Scale - fourth edition	baseline and 3 months
Primary	Change from 3-months Perceptual Reasoning Index at 9 months	Composite score of the Wechsler Adult Intelligence Scale - fourth edition	3 months and 9 months
Secondary	Working Memory Index	Composite score of the Wechsler Adult Intelligence Scale - fourth edition	baseline, 3 months and 9 months
Secondary	Processing Speed Index	Composite score of the Wechsler Adult Intelligence Scale - fourth edition	baseline, 3 months and 9 months
Secondary	Rey Auditory Verbal Learning Test	Neuropsychological test assessing verbal memory	baseline, 3 months and 9 months
Secondary	Cardebat's Verbal Fluencies	Neuropsychological test	baseline, 3 months and 9 months
Secondary	Emotion Hexagon	Task from the Facial Expressions of Emotion: Stimuli and Tests scale, assessing the recognition of emotions on faces	baseline, 3 months and 9 months
Secondary	Key Search Test	Task from the Behavioral Assessment of the Dysexecutive Syndrome scale, assessing planing abilities	baseline, 3 months and 9 months
Secondary	Stroop Color Word Test	Neuropsychological test assessing inhibition abilities	baseline, 3 months and 9 months
Secondary	Hamilton Depression Rating Scale		15 days before baseline, 3 months and 9 months
Secondary	Young Mania Rating Scale		15 days before baseline, 3 months and 9 months
Secondary	Functional Repercussions Scale	Self-assessment scale evaluating the consequences of cognitive impairments in daily life	baseline, 3 months and 9 months
Secondary	Social Desirability Scale	Self-assessment scale	baseline, 3 months and 9 months
Secondary	Social Relationships Scale	Self-assessment scale	baseline, 3 months and 9 months
Secondary	Self-Appraisal of Illness Questionnaire	Self-assessment scale	baseline, 3 months and 9 months
Secondary	Rorschach Inkblot Test		baseline, 3 months and 9 months
Secondary	Change from baseline Event-Related Potentials [ERP] P300 at 3 months during an Oddball task	Assessed for the first third of included patients	baseline and 3 months
Secondary	Change from baseline Event-Related Potentials [ERP] N2/P3 complex at 3 months during an emotional Stroop task	Assessed for the first third of included patients	baseline and 3 months
Secondary	Change from baseline serum Brain-Derived Neurotrophic Factor [BDNF] level (ng/mL) at 3 months	Assessed for the second third of included patients	baseline and 3 months
Secondary	Change from baseline functional Magnetic Resonance Imaging frontal activation at 3 months during an emotion recognition task	Assessed for the last third of included patients	baseline and 3 months