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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

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.

Condition or disease Intervention/treatment Phase
BD Drug: MPH Drug: Placebo Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Diagnostic
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).
Study Start Date : January 2014
Estimated Primary Completion Date : December 2014


Arm Intervention/treatment
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.
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



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02020200


Contacts
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Contact: Yael Lewis, MD +97297478644 yaelle4@clalit.org.il
Contact: Yechiel Levkovitz, MD, PhD +97297478644

Locations
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Israel
Shalvata MHC
Hod HaSharon, Israel
Sponsors and Collaborators
Shalvata Mental Health Center
Investigators
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Principal Investigator: Yechiel Levkovitz, MD, PhD Shalavata MHC
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Responsible Party: Shalvata Mental Health Center
ClinicalTrials.gov Identifier: NCT02020200    
Other Study ID Numbers: 0021-12-SHA
First Posted: December 24, 2013    Key Record Dates
Last Update Posted: December 24, 2013
Last Verified: December 2013
Keywords provided by Shalvata Mental Health Center:
Bipolar Disorder
Methylphenidate
Cognitive Function
Additional relevant MeSH terms:
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Bipolar Disorder
Bipolar and Related Disorders
Mental Disorders
Methylphenidate
Central Nervous System Stimulants
Physiological Effects of Drugs
Dopamine Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Dopamine Agents
Neurotransmitter Agents