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

NCT01426984 | Unknown DMC

• 1 other identifier: SHA -0011-11
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Borderline Personality Disorder

Outcome Measures

Primary Outcomes (5)

• 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.

  20 minutes

• 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

  30 minutes

• 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).

  30 minutes

• Spatial Working Memory (SWM) score

  CANTAB task for assessing Spatial Working Memory

  10 minutes

• digit span score

  Forward and Backward digit-span task (Wechsler 1981)

  20 minutes

Study Arms (1)

BPD adults

EXPERIMENTAL

adults with Borderline Personality Disorder (BPD)

Drug: methylphenidate

Interventions

methylphenidate DRUG

a capsule containing 20 mg

Also known as: Adults with Borderline Personality Disorder

BPD adults

Eligibility Criteria

• Age: 21 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Adults in the age of 21-50 with diagnosed with Borderline Personality Disorder (BPD)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shalvata Mental Health Center: lead

Study Sites (1)

Shalvata Mental Health center

Hod HaSharon, Israel

RECRUITING

MeSH Terms

Conditions

Borderline Personality Disorder

Interventions

Methylphenidate

Condition Hierarchy (Ancestors)

Personality Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Phenylacetates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Hilik Levkovitz, Prof.

  Shalvata MHC

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hila Gvirts, MA

CONTACT

97297478644; hilagv@clalit.org.il

Nirit Agay, Msc

CONTACT

97297478644; niritag@clalit.org.il

Study Design

• Study Type: interventional
• Phase: not applicable
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: DIAGNOSTIC
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 28, 2011
• First Posted: September 1, 2011
• Study Start: May 1, 2012
• Primary Completion: May 1, 2013
• Study Completion: May 1, 2013
• Last Updated: August 23, 2012

Record last verified: 2012-08

Locations

IL (1)