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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01426984
Recruitment Status : Unknown
Verified August 2012 by Shalvata Mental Health Center.
Recruitment status was:  Recruiting
First Posted : September 1, 2011
Last Update Posted : August 23, 2012
Information provided by (Responsible Party):
Shalvata Mental Health Center

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Borderline Personality Disorder Drug: methylphenidate Not Applicable

Detailed Description:

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Diagnostic
Official Title: A Double Blind Crossover Study on the Effect of Methylphenidate on Decision-making Ability of Adults With Borderline Personality Disorder (BPD) Compared to Adults With Attention Deficit Hyperactivity Disorder (ADHD) and Healthy Adults
Study Start Date : May 2012
Estimated Primary Completion Date : May 2013
Estimated Study Completion Date : May 2013

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: BPD adults
adults with Borderline Personality Disorder (BPD)
Drug: methylphenidate
a capsule containing 20 mg
Other Name: Adults with Borderline Personality Disorder

Primary Outcome Measures :
  1. Test of Variables of Attention (TOVA) score [ Time Frame: 20 minutes ]

    This test, devised by Greenberg and Kindschi (1996), is one of many continuous performance tests (CPTs), rapid reaction-time tasks in which participants have to discriminate predetermined target stimuli from distracting non-targets. CPTs, and TOVA among them, are widely used both by practitioners and investigators as an objective tool for assessing ADHD and determining beneficial medical effects (Llorente et al. 2001).

    The TOVA used here is a standardized, fixed-interval (21.6 ± 1.1 min), visual CPT.

  2. Iowa gambling task (IGT) score [ Time Frame: 30 minutes ]
    a computerized version of the Iowa Gambling Task (Bechara et al. 1994), which assesses reward learning. In this task the participant is presented with four decks of cards on the computer screen. Each card yields a reward, but might also cast a loss. In each trial, the participant selects a card out of one of the four decks by clicking on it. Consequently, the card is exposed, displaying the gain and the loss for that trial. The accumulated total amount is presented at the bottom of the screen all along, and is updated after every trial. Through contingent feedback, participants are expected to learn that decks A and B yield constant large gains but also larger losses, so that their net loss across trials is 2,500 tokens, whereas decks C and D yield smaller gains but also smaller losses, leading to a net gain across trials of 2,500 tokens

  3. Foregone Payoff Gambling Task (FPGT) score [ Time Frame: 30 minutes ]
    gambling task is a version of the IGT developed for the purpose of the current study. Two differences distinguish it from the original version - a different payoff distribution as detailed in Table 3, and a feedback method called foregone payoffs: following each choice made by the participants, they get to see not only the card chosen but also the other three cards from the three decks not chosen. This provides more information, but can also cause temptation, and may distract participants from the advantageous decks (see e.g., Yechiam et al. 2005; Yechiam and Busemeyer 2006).

  4. Spatial Working Memory (SWM) score [ Time Frame: 10 minutes ]
    CANTAB task for assessing Spatial Working Memory

  5. digit span score [ Time Frame: 20 minutes ]
    Forward and Backward digit-span task (Wechsler 1981)

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01426984

Contact: Hila Gvirts, MA 97297478644
Contact: Nirit Agay, Msc 97297478644

Shalvata Mental Health center Recruiting
Hod Hasharon,, Israel
Sponsors and Collaborators
Shalvata Mental Health Center
Principal Investigator: Hilik Levkovitz, Prof. Shalvata MHC

Responsible Party: Shalvata Mental Health Center Identifier: NCT01426984     History of Changes
Other Study ID Numbers: SHA -0011-11
First Posted: September 1, 2011    Key Record Dates
Last Update Posted: August 23, 2012
Last Verified: August 2012

Additional relevant MeSH terms:
Attention Deficit Disorder with Hyperactivity
Personality Disorders
Borderline Personality Disorder
Attention Deficit and Disruptive Behavior Disorders
Neurodevelopmental Disorders
Mental Disorders
Central Nervous System Stimulants
Physiological Effects of Drugs
Dopamine Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Dopamine Agents
Neurotransmitter Agents