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

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ClinicalTrials.gov Identifier: NCT02020200
Recruitment Status : Unknown
Verified December 2013 by Shalvata Mental Health Center.
Recruitment status was:  Not yet recruiting
First Posted : December 24, 2013
Last Update Posted : December 24, 2013
Sponsor:
Information provided by (Responsible Party):
Shalvata Mental Health Center

Tracking Information
First Submitted Date  ICMJE December 14, 2013
First Posted Date  ICMJE December 24, 2013
Last Update Posted Date December 24, 2013
Study Start Date  ICMJE January 2014
Estimated Primary Completion Date December 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (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  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (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  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Effect of Methylphenidate on Cognitive Abilities of Adults With Bipolar Disorder
Official Title  ICMJE 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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Diagnostic
Condition  ICMJE BD
Intervention  ICMJE
  • 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  ICMJE 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

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: December 23, 2013)
40
Original Estimated Enrollment  ICMJE Same as current
Study Completion Date  ICMJE Not Provided
Estimated Primary Completion Date December 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 21 Years to 50 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Israel
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02020200
Other Study ID Numbers  ICMJE 0021-12-SHA
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Shalvata Mental Health Center
Study Sponsor  ICMJE Shalvata Mental Health Center
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Yechiel Levkovitz, MD, PhD Shalavata MHC
PRS Account Shalvata Mental Health Center
Verification Date December 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP