N/A
N=72
Treatment to Enhance Cognition in Bipolar Disorder
Bipolar Disorder · Psychosis
Bottom Line
View on ClinicalTrials.gov: NCT01470781 ↗Enrolled (actual)
72
Serious AEs
0.0%
Results posted
Feb 2020
Primary outcome: Primary: MATRICS Consensus Cognitive Battery (MCCB) — 45.2; 45.5; 47.7; 49.3 T-scores
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- BrainWorks (Behavioral); Computer Control (Behavioral)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- Mclean Hospital
- Primary completion
- Aug 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY MATRICS Consensus Cognitive Battery (MCCB) |
45.2; 45.5; 47.7; 49.3; 50.3; 48.6 | — |
| SECONDARY Young Mania Rating Scale (YMRS) |
5.6; 4.6; 3.2; 4.5; 8.1; 4.1 | — |
| SECONDARY Montgomery-Asberg Depression Rating Scale (MADRS) |
11.8; 12.1; 9.5; 10.3; 12.1; 8.3 | — |
| SECONDARY Positive and Negative Syndrome Scale (PANSS) |
47.5; 45.6; 44.3; 44.0; 50.4; 42.9 | — |
| SECONDARY Multnomah Community Ability Scale (MCAS) |
47.7; 48.3; 48.7; 49.0; 47.2; 48.7 | — |
| SECONDARY Social and Occupational Functioning Assessment Scale |
59.4; 55.9; 58.1; 59.2; 58.2; 62.8 | — |
Summary
The purpose of the present study is to evaluate a neuroplasticity-oriented, computer-based cognitive remediation treatment program in patients with bipolar disorder and its effects on cognitive deficits and community functioning compared to an active, computer-based control.
Eligibility Criteria
Inclusion Criteria
- Clinical diagnosis of BD with psychosis
- Positive and Negative syndrome Scale (PANSS) 75; PANSS Psychosis item scores >3; YMRS > 6
- Legal or mental incompetence (legal incompetence defined by any guardianship (including of person or treatment guardianship); mental incompetence defined by failure of the informed consent survey)
- Psychiatric inpatient status at time of enrollment
- Delirium secondary to medical illness
- Psychotic or mood disorder due to general medical or neurological illness
- History of head trauma
- History of seizure disorder or photo-sensitive seizures
- Use of anticholinergic medication, clozapine or olanzapine at baseline
- Rapid-cycling bipolar disorder
- Diagnosis of current substance abuse (past month) or substance dependence within the past year.
Data sourced from ClinicalTrials.gov (NCT01470781). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.