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

August 28, 2011
August 22, 2012
May 2012
May 2013   (final data collection date for primary outcome measure)
  • 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)
  • TOVA score [ Time Frame: 20 minutes ] [ Designated as safety issue: No ]
  • FPGT score [ Time Frame: 30 minutes ] [ Designated as safety issue: No ]
  • SWM score [ Time Frame: 15 minutes ] [ Designated as safety issue: No ]
  • digit span score [ Time Frame: 20 minutes ] [ Designated as safety issue: No ]
  • IGT score [ Time Frame: 30 minutes ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01426984 on ClinicalTrials.gov Archive Site
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Not Provided
Not Provided
Not Provided
 
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
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

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.

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.

Interventional
Not Provided
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Diagnostic
Borderline Personality Disorder
Drug: methylphenidate
a capsule containing 20 mg
Other Name: Adults with Borderline Personality Disorder
Experimental: BPD adults
adults with Borderline Personality Disorder (BPD)
Intervention: Drug: methylphenidate
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
20
May 2013
May 2013   (final data collection date for primary outcome measure)

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.
Both
21 Years to 50 Years
No
Contact: Hila Gvirts, MA 97297478644 hilagv@clalit.org.il
Contact: Nirit Agay, Msc 97297478644 niritag@clalit.org.il
Israel
 
NCT01426984
SHA -0011-11
Yes
Shalvata Mental Health Center
Shalvata Mental Health Center
Not Provided
Principal Investigator: Hilik Levkovitz, Prof. Shalvata MHC
Shalvata Mental Health Center
August 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP