BD Clinical Trial
Official title:
A Crossover Study on the Effect of Methylphenidate (MPH) on Cognitive Abilities of Adults With Bipolar Disorder (BD), During Remission or Depressed State, Compared With Healthy Adults and Adults With Attention Deficit Hyperactivity Disorder (ADHD).
The purpose of the study is to explore the effect of MPH on working memory, attention and decision making in adults with BD in remission or in depressed state. The results will be compared to findings in healthy adults and adults with ADHD. The investigators hypothesize that MPH will incur improved performance in all measures.
| Status | Not yet recruiting |
| Enrollment | 40 |
| Est. completion date | |
| Est. primary completion date | December 2014 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 21 Years to 50 Years |
| Eligibility |
Inclusion Criteria: - Hebrew Speakers - Age 21-50 - Diagnosis of BD I or II (296.7 and 296.89 classifications in the DSM-IV-TR), according to medical records. Diagnosis will be confirmed by a psychiatrist during screening process using the Structured Clinical Interview for DSM-IV-TR (SCID). Exclusion Criteria: - Diagnosis of a clinical disorder other than BD or ADD/ADHD which may impair performance on tasks used in the study. - BD patients diagnosed with an acute manic episode at screening, as established by YMRS>8. It will also be required that 3 months have elapsed since the latest manic state, according to the patients' history. - Participants for whom there exists a contra-indication for consuming Ritalin. - Pregnancy or current breastfeeding; Female participants will be asked to report whether they are pregnant or currently nursing and if so, they will be excluded from the study. - Drug use in the previous 6 weeks according to participants' self report - Electroconvulsive therapy (ECT) in the previous 6 months |
Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Diagnostic
| Country | Name | City | State |
|---|---|---|---|
| Israel | Shalvata MHC | Hod HaSharon |
| Lead Sponsor | Collaborator |
|---|---|
| Shalvata Mental Health Center |
Israel,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Cognitive function. | Cognitive function will be measured by scores on several computerized neuro-psychological and decision making tasks: digit-span task, spatial working memory task, raven's progressive matrices, test of variable attention and the Iowa gambling task. | Within 4 hours of intervention. | No |
| Secondary | Creativity abilities. | Creativity will be measured by scores on two tests: the alternative use task and two subsets of the Torrance tests for creative thinking. | Within 4 hours of intervention. | No |