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

NCT02020200 | Unknown

• 1 other identifier: 0021-12-SHA
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

BD

Keywords

Bipolar Disorder; Methylphenidate; Cognitive Function

Outcome Measures

Primary Outcomes (1)

• 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.

  Within 4 hours of intervention.

Secondary Outcomes (1)

• Creativity abilities.

  Within 4 hours of intervention.

Study Arms (1)

MPH or Placebo

EXPERIMENTAL

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; Drug: Placebo

Interventions

MPH 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.

Also known as: Ritalin

MPH or Placebo

Placebo DRUG

MPH or Placebo

Eligibility Criteria

• Age: 21 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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).

You may not qualify if:

• 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

Sponsors & Collaborators

• Shalvata Mental Health Center: lead

Study Sites (1)

Shalvata MHC

Hod HaSharon, Israel

Location

MeSH Terms

Conditions

Bipolar Disorder

Interventions

5,10-dihydro-5-methylphenazine; Methylphenidate

Condition Hierarchy (Ancestors)

Bipolar and Related Disorders; Mood Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Phenylacetates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Yechiel Levkovitz, MD, PhD

  Shalavata MHC

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yael Lewis, MD

CONTACT

+97297478644; yaelle4@clalit.org.il

Yechiel Levkovitz, MD, PhD

CONTACT

+97297478644

Study Design

• Study Type: interventional
• Phase: not applicable
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: DIAGNOSTIC
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 14, 2013
• First Posted: December 24, 2013
• Study Start: January 1, 2014
• Primary Completion: December 1, 2014
• Last Updated: December 24, 2013

Record last verified: 2013-12

Locations

IL (1)