High Risk MC4R Genotype Clinical Trial
Official title:
1/2-MC4R Genotype and Pediatric Antipsychotic Drug- Induced Weight Gain
| Verified date | January 2016 |
| Source | Northwell Health |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | United States: Institutional Review Board |
| Study type | Interventional |
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 aged 13-18 years old. Patients will have 10 days or less lifetime antipsychotic exposure and be in clinical need for antipsychotic treatment for a pediatric psychiatric disorder with FDA indication for antipsychotic use, i.e., bipolar mania, schizophrenia-spectrum disorders, and irritability associated with autistic disorder. In addition, we will also include youth fulfilling research diagnostic criteria for severe mood dysregulation (SMD). Randomization will be stratified by high vs. low genetic risk for antipsychotic-induced weight gain based on MC4R genotype and the primary outcome will be weight change from baseline to endpoint between ZIP and UC antipsychotic treatment in each of the two genotype groups. As detailed below, other metabolic and cardiac safety parameters will also be measured and compared across treatments in each of the genotype groups.
| Status | Terminated |
| Enrollment | 14 |
| Est. completion date | April 2014 |
| Est. primary completion date | April 2014 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 13 Years to 18 Years |
| Eligibility |
Inclusion Criteria: - 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 Criteria: - 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. |
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label
| Country | Name | City | State |
|---|---|---|---|
| United States | Zucker Hillside Hospital, Psychiatry Research | Glen Oaks | New York |
| Lead Sponsor | Collaborator |
|---|---|
| Northwell Health |
United States,
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* Note: There are 87 references in all — Click here to view all references
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Weight Change | baseline to week 12 | No | |
| Secondary | Percent Weight Change Compared to Baseline Weight | baseline to week 12 | No | |
| Secondary | BMI Z-scores | baseline to week 12 | No | |
| Secondary | BMI Percentile | baseline to week 12 | No |