The Effect of Methylphenidate on Cognitive Abilities of Adults With Bipolar Disorder

• ClinicalTrials.gov Identifier: NCT02020200
• Recruitment Status: Unknown
• First Posted: December 24, 2013
• Last Update Posted: December 24, 2013
• Sponsor: Shalvata Mental Health Center
• Information provided by (Responsible Party): Shalvata Mental Health Center

Tracking Information

• First Submitted Date: December 14, 2013
• First Posted Date: December 24, 2013
• Last Update Posted Date: December 24, 2013
• Study Start Date: January 2014
• Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: December 23, 2013)

Cognitive function. [ Time Frame: Within 4 hours of intervention. ]

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.

• Original Primary Outcome Measures: Same as current
• Change History: No Changes Posted

Current Secondary Outcome Measures (submitted: December 23, 2013)

Creativity abilities. [ Time Frame: Within 4 hours of intervention. ]

Creativity will be measured by scores on two tests: the alternative use task and two subsets of the Torrance tests for creative thinking.

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: The Effect of Methylphenidate on Cognitive Abilities of Adults With Bipolar Disorder
• 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).
• Brief Summary: 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.
• Detailed Description: Following a detailed explanation about the trial and after obtaining informed consent from candidates, subjects will be asked to arrive at the cognitive laboratory at Shalvata MHC twice. Visits will include performance of computerized cognitive and decision making tasks, as well as two creativity tasks after the consumption of MPH or placebo.
• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Intervention Model: Crossover Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Diagnostic
• Condition: BD

Intervention

• Drug: MPH
  MPH dosage will be determined according to participants' body weight: dosage: 10 mg in case weight<40 kg; 30 mg in case weight>90 kg; otherwise 20 mg.
  Other Name: Ritalin
• Drug: Placebo

Study Arms

Experimental: MPH or Placebo

MPH dosage will be determined according to participants' body weight: dosage: 10 mg in case weight<40 kg; 30 mg in case weight>90 kg; otherwise 20 mg. Both participants and investigators will be blinded to when participant receives MPH or Placebo.

Interventions:

• Drug: MPH
• Drug: Placebo

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Unknown status
• Estimated Enrollment (submitted: December 23, 2013): 40
• Original Estimated Enrollment: Same as current
• Study Completion Date: Not Provided
• Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)

Eligibility Criteria

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 21 Years to 50 Years (Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Israel

Administrative Information

• NCT Number: NCT02020200
• Other Study ID Numbers: 0021-12-SHA
• Has Data Monitoring Committee: Not Provided
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Shalvata Mental Health Center
• Study Sponsor: Shalvata Mental Health Center
• Collaborators: Not Provided

Investigators

• Principal Investigator: Yechiel Levkovitz, MD, PhD; Shalavata MHC

• PRS Account: Shalvata Mental Health Center
• Verification Date: December 2013