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
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|ClinicalTrials.gov 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
|Condition or disease||Intervention/treatment||Phase|
|Borderline Personality Disorder||Drug: methylphenidate||Not Applicable|
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)|
|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|
Experimental: BPD adults
adults with Borderline Personality Disorder (BPD)
a capsule containing 20 mg
Other Name: Adults with Borderline Personality Disorder
- 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.
- 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
- 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).
- Spatial Working Memory (SWM) score [ Time Frame: 10 minutes ]CANTAB task for assessing Spatial Working Memory
- digit span score [ Time Frame: 20 minutes ]Forward and Backward digit-span task (Wechsler 1981)
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 ClinicalTrials.gov identifier (NCT number): NCT01426984
|Contact: Hila Gvirts, MAfirstname.lastname@example.org|
|Contact: Nirit Agay, Mscemail@example.com|
|Shalvata Mental Health center||Recruiting|
|Hod Hasharon,, Israel|
|Principal Investigator:||Hilik Levkovitz, Prof.||Shalvata MHC|