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Methylphenidate Neural Response in Disruptive Behavioral Disorder
NCT02247986Phase 2
Key facts
- Status
- Withdrawn
- Start
- Sep 2014
- Primary completion
- May 2015
- Sponsor
- National Institute of Mental Health
- Modality
- Small Molecules
- Drugs
- methylphenidate
- Conditions
- conduct disorder (CD)oppositional defiant disorder (ODD)
01
Overview
Phase 2, randomised, double-blind trial of methylphenidate in conduct disorder (CD) and oppositional defiant disorder (ODD) (2 arms), sponsored by National Institute of Mental Health. Primary endpoints: BOLD response in amygdala to fearful expressions at 2 years, BOLD response in striatum and ventromedial frontal cortex at 2 years and 1 more. Planned start Sep 2014; status: withdrawn.
02
Design
2 arms- Study design
- RandomizedDouble-blind
CD/ODD Group
Youth with Conduct Disorder/ODD receiving Methylphenidate and Placebo in crossover order.
Healthy Volunteers
Healthy youth receiving no medication.
03
Who it enrols
Youth aged 10-17 with Conduct Disorder (CD) or Oppositional Defiant Disorder (ODD), with or without comorbid ADHD, who are naive to psychoactive medication. Healthy volunteers of the same age are also included.
04
Endpoints
Primary
BOLD response in amygdala to fearful expressions
BOLD response in striatum and ventromedial frontal cortex
BOLD response in dorsomedial, lateral and parietal cortices
Secondary
Correlation of symptom profiles with BOLD signal changes
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