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

NCT ID: NCT02020200

Last Updated: 2013-12-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-01-31

Brief Summary

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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

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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.

Conditions

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BD

Keywords

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Bipolar Disorder Methylphenidate Cognitive Function

Study Design

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Intervention Model

CROSSOVER

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

MPH

Intervention Type DRUG

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.

Placebo

Intervention Type DRUG

Interventions

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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.

Intervention Type DRUG

Placebo

Intervention Type DRUG

Other Intervention Names

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Ritalin

Eligibility Criteria

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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
Minimum Eligible Age

21 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Shalvata Mental Health Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Yechiel Levkovitz, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Shalavata MHC

Locations

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Shalvata MHC

Hod HaSharon, , Israel

Site Status

Countries

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Israel

Central Contacts

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Yael Lewis, MD

Role: CONTACT

Phone: +97297478644

Email: [email protected]

Yechiel Levkovitz, MD, PhD

Role: CONTACT

Phone: +97297478644

Other Identifiers

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0021-12-SHA

Identifier Type: -

Identifier Source: org_study_id