Status:
TERMINATED
1/2-MC4R Genotype and Pediatric Antipsychotic Drug- Induced Weight Gain
Lead Sponsor:
Northwell Health
Conditions:
High Risk MC4R Genotype
Low Risk MC4R Genotype
Eligibility:
All Genders
13-18 years
Phase:
PHASE4
Brief Summary
We will conduct a 12-week, randomized open label study, comparing usual care (UC) antipsychotic treatment (aripiprazole, quetiapine, risperidone) with ziprasidone (ZIP) in children and adolescents age...
Eligibility Criteria
Inclusion
- age 13-18 years
- English-speaking
- DSM diagnoses that have an FDA indication for SGA use for at least one agent in the respective pediatric or adult age group. Specifically, primary DSM-IV diagnosis of early-onset schizophrenia spectrum disorders; bipolar I disorder mania (and BP-NOS); irritability associated with autism spectrum disorder, as well as severe mood dysregulation (SMD) according to Leibenluft et al. (2011) with an ABC-irritability score of \>/=18 Sexually active girls must agree to use two effective forms of birth control or be abstinent
- Participant has a primary caretaker who has known the child well for at least 6 months before study entry Primary caretaker is able to participate in study appointments
- Ability of child to participate in all aspects of the protocol per investigator clinical judgment.
Exclusion
- Major neurological or medical illnesses that affect weight (e.g., unstable thyroid disease), require a prohibited systemic medication (e.g., diabetes mellitus \[insulin\], chronic renal failure \[steroids); Fasting glucose \> 125 mg/dL on 2 occasions during screening
- Any medication (other than currently prescribed psychotropic medications) that would significantly alter weight
- Antidepressants not allowed for at least 2 weeks in BP-I or BP-NOS patients
- DSM-IV diagnosis of anorexia or bulimia nervosa
- DSM-IV diagnosis of Substance Dependence disorder (other than tobacco dependence) within the past month
- Initial urine toxicology screen and follow-up screen indicate ongoing use of illicit substance
- Hypersensitivity to ZIP or UC antipsychotics
- Pregnant, breast feeding or unwilling to comply with contraceptive requirements
- Screening or baseline QTc \> 450 msec
- IQ \< 55
- Significant risk for dangerousness to self or to others
- Ongoing or previously undisclosed child abuse requiring new department of social service intervention.
Key Trial Info
Start Date :
July 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2014
Estimated Enrollment :
14 Patients enrolled
Trial Details
Trial ID
NCT01844700
Start Date
July 1 2013
End Date
April 1 2014
Last Update
February 5 2016
Active Locations (1)
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1
Zucker Hillside Hospital, Psychiatry Research
Glen Oaks, New York, United States, 11004