Clinical trial NCT02698696: Validation of a Cognitive Remediation Program for Bipolar Disorders
Official title: Validation of a Cognitive Remediation Program for Bipolar Disorders
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Bipolar Disorder
Keywords: Cognitive Remediation
Mood disorders
Neuropsychology
Lead sponsor: Centre hospitalier de Ville-Evrard, France
Sponsor class: OTHER
First posted: 2016-03-04
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.


Eligibility criteria: 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.)

Primary outcomes:
measure: Change from baseline Perceptual Reasoning Index at 3 months
timeFrame: baseline and 3 months
measure: Change from 3-months Perceptual Reasoning Index at 9 months
timeFrame: 3 months and 9 months
Secondary outcomes:
measure: Working Memory Index
timeFrame: baseline, 3 months and 9 months
measure: Processing Speed Index
timeFrame: baseline, 3 months and 9 months
measure: Rey Auditory Verbal Learning Test
timeFrame: baseline, 3 months and 9 months
measure: Cardebat's Verbal Fluencies
timeFrame: baseline, 3 months and 9 months
measure: Emotion Hexagon
timeFrame: baseline, 3 months and 9 months
measure: Key Search Test
timeFrame: baseline, 3 months and 9 months
measure: Stroop Color Word Test
timeFrame: baseline, 3 months and 9 months
measure: Hamilton Depression Rating Scale
timeFrame: 15 days before baseline, 3 months and 9 months
measure: Young Mania Rating Scale
timeFrame: 15 days before baseline, 3 months and 9 months
measure: Functional Repercussions Scale
timeFrame: baseline, 3 months and 9 months
measure: Social Desirability Scale
timeFrame: baseline, 3 months and 9 months
measure: Social Relationships Scale
timeFrame: baseline, 3 months and 9 months
measure: Self-Appraisal of Illness Questionnaire
timeFrame: baseline, 3 months and 9 months
measure: Rorschach Inkblot Test
timeFrame: baseline, 3 months and 9 months
measure: Change from baseline Event-Related Potentials [ERP] P300 at 3 months during an Oddball task
timeFrame: baseline and 3 months
measure: Change from baseline Event-Related Potentials [ERP] N2/P3 complex at 3 months during an emotional Stroop task
timeFrame: baseline and 3 months
measure: Change from baseline serum Brain-Derived Neurotrophic Factor [BDNF] level (ng/mL) at 3 months
timeFrame: baseline and 3 months
measure: Change from baseline functional Magnetic Resonance Imaging frontal activation at 3 months during an emotion recognition task
timeFrame: baseline and 3 months
Other outcomes:
Locations:
city: Neuilly-sur-Marne
country: France
facility: Unité de Recherche Clinique, EPS Ville Evrard
Study officials:
affiliation: Unité de Recherche Clinique, EPS Ville Evrard
name: Clémence Isaac, Psychologist
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
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):298-307. doi: 10.1111/j.1755-5949.2009.00110.x.
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.