Bipolar Disorder
Conditions
Keywords
Cognitive Remediation, Mood disorders, Neuropsychology
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.
Interventions
OTHERECo program
OTHERCRT program
OTHERSupportive psychotherapy
Sponsors
Centre hospitalier de Ville-Evrard, France
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
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.)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline Perceptual Reasoning Index at 3 months | baseline and 3 months | Composite score of the Wechsler Adult Intelligence Scale - fourth edition |
| Change from 3-months Perceptual Reasoning Index at 9 months | 3 months and 9 months | Composite score of the Wechsler Adult Intelligence Scale - fourth edition |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Rey Auditory Verbal Learning Test | baseline, 3 months and 9 months | Neuropsychological test assessing verbal memory |
| Cardebat's Verbal Fluencies | baseline, 3 months and 9 months | Neuropsychological test |
| Emotion Hexagon | baseline, 3 months and 9 months | Task from the Facial Expressions of Emotion: Stimuli and Tests scale, assessing the recognition of emotions on faces |
| Key Search Test | baseline, 3 months and 9 months | Task from the Behavioral Assessment of the Dysexecutive Syndrome scale, assessing planing abilities |
| Stroop Color Word Test | baseline, 3 months and 9 months | Neuropsychological test assessing inhibition abilities |
| Hamilton Depression Rating Scale | 15 days before baseline, 3 months and 9 months | — |
| Young Mania Rating Scale | 15 days before baseline, 3 months and 9 months | — |
| Functional Repercussions Scale | baseline, 3 months and 9 months | Self-assessment scale evaluating the consequences of cognitive impairments in daily life |
| Working Memory Index | baseline, 3 months and 9 months | Composite score of the Wechsler Adult Intelligence Scale - fourth edition |
| Social Relationships Scale | baseline, 3 months and 9 months | Self-assessment scale |
| Self-Appraisal of Illness Questionnaire | baseline, 3 months and 9 months | Self-assessment scale |
| Rorschach Inkblot Test | baseline, 3 months and 9 months | — |
| Change from baseline Event-Related Potentials [ERP] P300 at 3 months during an Oddball task | baseline and 3 months | Assessed for the first third of included patients |
| Change from baseline Event-Related Potentials [ERP] N2/P3 complex at 3 months during an emotional Stroop task | baseline and 3 months | Assessed for the first third of included patients |
| Change from baseline serum Brain-Derived Neurotrophic Factor [BDNF] level (ng/mL) at 3 months | baseline and 3 months | Assessed for the second third of included patients |
| Change from baseline functional Magnetic Resonance Imaging frontal activation at 3 months during an emotion recognition task | baseline and 3 months | Assessed for the last third of included patients |
| Social Desirability Scale | baseline, 3 months and 9 months | Self-assessment scale |
| Processing Speed Index | baseline, 3 months and 9 months | Composite score of the Wechsler Adult Intelligence Scale - fourth edition |
Countries
France
Contacts
Primary ContactClémence Isaac, Psychologist
Backup ContactDominique Januel, MD Phd
Outcome results
None listed