1/2-MC4R Genotype and Pediatric Antipsychotic Drug- Induced Weight Gain
| Status: | Terminated |
|---|---|
| Conditions: | Obesity Weight Loss |
| Therapuetic Areas: | Endocrinology |
| Healthy: | No |
| Age Range: | 13 - 18 |
| Updated: | 4/21/2016 |
| Start Date: | July 2013 |
| End Date: | April 2014 |
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.
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.
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.
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