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 recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2012 by Shalvata Mental Health Center.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Shalvata Mental Health Center
ClinicalTrials.gov Identifier:
NCT01426984
First received: August 28, 2011
Last updated: August 22, 2012
Last verified: August 2012
  Purpose

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 Intervention
Borderline Personality Disorder
Drug: methylphenidate

Study Type: Interventional
Study Design: Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, 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

Resource links provided by NLM:


Further study details as provided by Shalvata Mental Health Center:

Primary Outcome Measures:
  • Test of Variables of Attention (TOVA) score [ Time Frame: 20 minutes ] [ Designated as safety issue: No ]

    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.


  • Iowa gambling task (IGT) score [ Time Frame: 30 minutes ] [ Designated as safety issue: No ]
    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

  • Foregone Payoff Gambling Task (FPGT) score [ Time Frame: 30 minutes ] [ Designated as safety issue: No ]
    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).

  • Spatial Working Memory (SWM) score [ Time Frame: 10 minutes ] [ Designated as safety issue: No ]
    CANTAB task for assessing Spatial Working Memory

  • digit span score [ Time Frame: 20 minutes ] [ Designated as safety issue: No ]
    Forward and Backward digit-span task (Wechsler 1981)


Estimated Enrollment: 20
Study Start Date: May 2012
Estimated Study Completion Date: May 2013
Estimated Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: BPD adults
adults with Borderline Personality Disorder (BPD)
Drug: methylphenidate
a capsule containing 20 mg
Other Name: Adults with Borderline Personality Disorder

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.

  Eligibility

Ages Eligible for Study:   21 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01426984

Contacts
Contact: Hila Gvirts, MA 97297478644 hilagv@clalit.org.il
Contact: Nirit Agay, Msc 97297478644 niritag@clalit.org.il

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

No publications provided

Responsible Party: Shalvata Mental Health Center
ClinicalTrials.gov Identifier: NCT01426984     History of Changes
Other Study ID Numbers: SHA -0011-11
Study First Received: August 28, 2011
Last Updated: August 22, 2012
Health Authority: Israel: Ministry of Health

Additional relevant MeSH terms:
Borderline Personality Disorder
Disease
Attention Deficit Disorder with Hyperactivity
Personality Disorders
Pathologic Processes
Attention Deficit and Disruptive Behavior Disorders
Mental Disorders Diagnosed in Childhood
Mental Disorders
Methylphenidate
Central Nervous System Stimulants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Dopamine Uptake Inhibitors
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Uptake Inhibitors

ClinicalTrials.gov processed this record on September 18, 2014