Treatment of Impulsive Aggression in Subjects With ADHD in Conjunction With Standard ADHD Treatment (CHIME 2)
| Status: | Recruiting | 
|---|---|
| Conditions: | Psychiatric, ADHD | 
| Therapuetic Areas: | Psychiatry / Psychology, Other | 
| Healthy: | No | 
| Age Range: | 6 - 12 | 
| Updated: | 3/11/2017 | 
| Start Date: | March 2015 | 
| Contact: | Stefan Schwabe, MD, PhD | 
| Email: | sschwabe@supernus.com | 
| Phone: | 301-838-2527 | 
The purpose of this study is to demonstrate the efficacy, safety and tolerability of SPN-810
in the treatment of impulsive aggression in patients with Attention Deficit/Hyperactivity
Disorder (ADHD) in conjunction with standard ADHD treatment. Approximately 291 subjects aged
6 to 12 years with ADHD and comorbid impulsive aggression will be recruited in this study.
The frequency of impulsive aggression behaviors will be assessed as a primary outcome.
Additionally, the severity and improvement in impulsive aggression, and quality of life
measures for the subject and caregiver will be assessed using validated scales.
			in the treatment of impulsive aggression in patients with Attention Deficit/Hyperactivity
Disorder (ADHD) in conjunction with standard ADHD treatment. Approximately 291 subjects aged
6 to 12 years with ADHD and comorbid impulsive aggression will be recruited in this study.
The frequency of impulsive aggression behaviors will be assessed as a primary outcome.
Additionally, the severity and improvement in impulsive aggression, and quality of life
measures for the subject and caregiver will be assessed using validated scales.
Inclusion Criteria:
- Otherwise healthy male or female subjects, age 6 to 12 years at the time of screening
with a primary diagnosis of ADHD and currently receiving monotherapy treatment with
an optimized FDA-approved ADHD medication.
- Impulsive aggression will be confirmed at screening using R-MOAS and Vitiello
Aggression Scale.
Exclusion Criteria:
- Current or lifetime diagnosis of epilepsy, major depressive disorder, bipolar
disorder, schizophrenia or related disorder, personality disorder, Tourette's
disorder, or psychosis not otherwise specified.
- Currently meeting DSM criteria for autism spectrum disorder, pervasive developmental
disorder, obsessive compulsive disorder, post-traumatic stress disorder, or any other
anxiety disorder as primary diagnosis.
- Known or suspected intelligence quotient (IQ) < 70, suicidality, pregnancy, or
substance or alcohol abuse.
We found this trial at
    25
    sites
	
									811 Juniper St NE
Atlanta, Georgia 30308
	
			Atlanta, Georgia 30308
(404) 881-5800
							
					Phone: 404-881-5800
					
		Atlanta Center for Medical Research Welcome to the Atlanta Center for Medical Research, a leader...  
  
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									2417 Marshall Ave.
Imperial, California 92251
	
			Imperial, California 92251
760-355-0176
					Phone: 760-545-0123
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									6141 Sunset Dr # 301
South Miami, Florida 33143
	
			South Miami, Florida 33143
(305) 598-3125
							
					Phone: 305-598-3125
					
		Miami Research Associates Miami Research Associates (MRA) is the largest privately-owned multi-specialty clinical research center...  
  
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								Cincinnati, Ohio 45219			
	
			
					Phone: 513-558-2989
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									10040 Regency Cir
Omaha, Nebraska 68114
	
			Omaha, Nebraska 68114
(402) 934-0044
							
					Phone: 402-934-0044
					
		Quality Clinical Research, Inc. Welcome to Quality Clinical Research. We originated here in Omaha, NE...  
  
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								St. Charles, Missouri 63304			
	
			
					Phone: 636-946-8032
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								Tampa, Florida 33613			
	
			
					Phone: 813-974-2832
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								Washington, District of Columbia 20310			
	
			
					Phone: 202-476-3042
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