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

Primary Purpose

BD

Status
Unknown status
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
MPH
Placebo
Sponsored by
Shalvata Mental Health Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for BD focused on measuring Bipolar Disorder, Methylphenidate, Cognitive Function

Eligibility Criteria

21 Years - 50 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Shalvata MHC

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

MPH or Placebo

Arm Description

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

First Posted
December 14, 2013
Last Updated
December 23, 2013
Sponsor
Shalvata Mental Health Center
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1. Study Identification

Unique Protocol Identification Number
NCT02020200
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).
Study Type
Interventional

2. Study Status

Record Verification Date
December 2013
Overall Recruitment Status
Unknown status
Study Start Date
January 2014 (undefined)
Primary Completion Date
December 2014 (Anticipated)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Shalvata Mental Health Center

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
BD
Keywords
Bipolar Disorder, Methylphenidate, Cognitive Function

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
MPH or Placebo
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
MPH
Other Intervention Name(s)
Ritalin
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
Cognitive function.
Description
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.
Time Frame
Within 4 hours of intervention.
Secondary Outcome Measure Information:
Title
Creativity abilities.
Description
Creativity will be measured by scores on two tests: the alternative use task and two subsets of the Torrance tests for creative thinking.
Time Frame
Within 4 hours of intervention.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yael Lewis, MD
Phone
+97297478644
Email
yaelle4@clalit.org.il
First Name & Middle Initial & Last Name or Official Title & Degree
Yechiel Levkovitz, MD, PhD
Phone
+97297478644
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yechiel Levkovitz, MD, PhD
Organizational Affiliation
Shalavata MHC
Official's Role
Principal Investigator
Facility Information:
Facility Name
Shalvata MHC
City
Hod HaSharon
Country
Israel

12. IPD Sharing Statement

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

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