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

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).

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02020200

Enrollment

Registered

2013-12-24

Start date

2014-01-31

Completion date

Unknown

Last updated

2013-12-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Keywords

Bipolar Disorder, Methylphenidate, Cognitive Function

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.

Interventions

DRUGMPH

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.

DRUGPlacebo

Study design

Intervention model

CROSSOVER

Primary purpose

DIAGNOSTIC

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

21 Years to 50 Years

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

Design outcomes

Primary

Measure	Time frame	Description
Cognitive function.	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

Measure	Time frame	Description
Creativity abilities.	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.

Countries

Israel

Contacts

Primary ContactYael Lewis, MD

yaelle4@clalit.org.il+97297478644

Backup ContactYechiel Levkovitz, MD, PhD

+97297478644

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026