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A Double Blind Crossover Study on the Effect of MPH on Decision-making Ability of Adults With BPD Compared to Adults With ADHD and Healthy Adults

NCT ID: NCT01426984

Last Updated: 2012-08-23

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

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-05-31

Study Completion Date

2013-05-31

Brief Summary

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The study assesses the effect of Ritalin on working memory,attention,and decision-making measures in adults with BPD and compares it to its effect on healthy adults and adults with BPD (using data form study SHA 01-10), in a double-blind crossover design. The investigators hypothesize that Ritalin will result in better performance in all measures.

Detailed Description

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Participants will be required to arrive at the cognitive laboratory in "Shalvata" for two visits: the first visit will include obtaining informed consent, screening (as detailed below), and performing a battery of computerized tasks. The second visit will include performing of the same battery of tasks, and payment.

In one of the visits, participants will receive a capsule containing Methylphenidate or placebo (MPH; Ritalin) (dosage: 10 mg in case weight\<40 kg; 30 mg in case weight\>90 kg; otherwise 20 mg -( The pills will be 10mg each, and the number of pills will be administered according to the dosage stated; 1-3 pills, according to weight). Prior to performing the tasks, and in the other visit they will receive a capsule containing placebo.

Conditions

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Borderline Personality Disorder

Study Design

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Intervention Model

CROSSOVER

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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BPD adults

adults with Borderline Personality Disorder (BPD)

Group Type EXPERIMENTAL

methylphenidate

Intervention Type DRUG

a capsule containing 20 mg

Interventions

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methylphenidate

a capsule containing 20 mg

Intervention Type DRUG

Other Intervention Names

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Adults with Borderline Personality Disorder

Eligibility Criteria

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Inclusion Criteria

* Adults in the age of 21-50 with diagnosed with Borderline Personality Disorder (BPD)

Exclusion Criteria

* People diagnosed with a clinical disorder other than BPD or ADD/ADHD that may impair their performance in the tasks used in the study.
* People for whom there is a contra-indication for consuming Ritalin.
* Pregnant women and nursing women; Women participants will be required to report whether they are pregnant, and in case they are, they will not participate.
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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Hilik Levkovitz, Prof.

Role: PRINCIPAL_INVESTIGATOR

Shalvata MHC

Locations

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Shalvata Mental Health center

Hod HaSharon, , Israel

Site Status RECRUITING

Countries

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Israel

Central Contacts

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Hila Gvirts, MA

Role: CONTACT

Phone: 97297478644

Email: [email protected]

Nirit Agay, Msc

Role: CONTACT

Phone: 97297478644

Email: [email protected]

Other Identifiers

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SHA -0011-11

Identifier Type: -

Identifier Source: org_study_id