Back to resultsA 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
Primary Purpose
Borderline Personality Disorder
Status
Unknown status
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
methylphenidate
Sponsored by
About this trial
This is an interventional diagnostic trial for Borderline Personality Disorder
Eligibility 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.
Sites / Locations
- Shalvata Mental Health centerRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
BPD adults
Arm Description
adults with Borderline Personality Disorder (BPD)
Outcomes
Primary Outcome Measures
Test of Variables of Attention (TOVA) score
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
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
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
CANTAB task for assessing Spatial Working Memory
digit span score
Forward and Backward digit-span task (Wechsler 1981)
Secondary Outcome Measures
Full Information
NCT ID
NCT01426984
First Posted
August 28, 2011
Last Updated
August 22, 2012
Sponsor
Shalvata Mental Health Center
1. Study Identification
Unique Protocol Identification Number
NCT01426984
Brief Title
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
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 Type
Interventional
2. Study Status
Record Verification Date
August 2012
Overall Recruitment Status
Unknown status
Study Start Date
May 2012 (undefined)
Primary Completion Date
May 2013 (Anticipated)
Study Completion Date
May 2013 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Shalvata Mental Health Center
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Borderline Personality Disorder
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
BPD adults
Arm Type
Experimental
Arm Description
adults with Borderline Personality Disorder (BPD)
Intervention Type
Drug
Intervention Name(s)
methylphenidate
Other Intervention Name(s)
Adults with Borderline Personality Disorder
Intervention Description
a capsule containing 20 mg
Primary Outcome Measure Information:
Title
Test of Variables of Attention (TOVA) score
Description
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.
Time Frame
20 minutes
Title
Iowa gambling task (IGT) score
Description
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
Time Frame
30 minutes
Title
Foregone Payoff Gambling Task (FPGT) score
Description
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).
Time Frame
30 minutes
Title
Spatial Working Memory (SWM) score
Description
CANTAB task for assessing Spatial Working Memory
Time Frame
10 minutes
Title
digit span score
Description
Forward and Backward digit-span task (Wechsler 1981)
Time Frame
20 minutes
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hila Gvirts, MA
Phone
97297478644
Email
hilagv@clalit.org.il
First Name & Middle Initial & Last Name or Official Title & Degree
Nirit Agay, Msc
Phone
97297478644
Email
niritag@clalit.org.il
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hilik Levkovitz, Prof.
Organizational Affiliation
Shalvata MHC
Official's Role
Principal Investigator
Facility Information:
Facility Name
Shalvata Mental Health center
City
Hod Hasharon,
Country
Israel
Individual Site Status
Recruiting
12. IPD Sharing Statement
Learn more about this trial
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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