Status:
COMPLETED
Treatment to Enhance Cognition in Bipolar Disorder
Lead Sponsor:
Mclean Hospital
Collaborating Sponsors:
National Institute of Mental Health (NIMH)
Conditions:
Bipolar Disorder
Psychosis
Eligibility:
All Genders
18-50 years
Phase:
NA
Brief 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 defici...
Detailed Description
Cognitive dysfunction is increasingly recognized as a major feature of bipolar disorder (BD), present by illness onset, persistent into euthymia, and associated with functional outcome. Deficits are q...
Eligibility Criteria
Inclusion
- Clinical diagnosis of BD with psychosis
- Positive and Negative syndrome Scale (PANSS) \< 75; PANSS Psychosis item scores = 3 or under; Young Mania Rating Scale (YMRS) = 6 or under
- Age between 18 and 50
- Within 10 years of illness onset
- Legal and mental competency of the participant
Exclusion
- Age under 18 or over 50
- 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.
Key Trial Info
Start Date :
June 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2016
Estimated Enrollment :
72 Patients enrolled
Trial Details
Trial ID
NCT01470781
Start Date
June 1 2011
End Date
August 1 2016
Last Update
September 28 2021
Active Locations (1)
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1
McLean Hospital
Belmont, Massachusetts, United States, 02478