1/2-MC4R Genotype and Pediatric Antipsychotic Drug- Induced Weight Gain

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2013 by North Shore Long Island Jewish Health System.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by (Responsible Party):
Anil K. Malhotra, North Shore Long Island Jewish Health System
ClinicalTrials.gov Identifier:
NCT01844700
First received: April 29, 2013
Last updated: April 30, 2013
Last verified: April 2013
  Purpose

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.


Condition Intervention Phase
High Risk MC4R Genotype
Low Risk MC4R Genotype
One Week or Less Antipsychotic Lifetime Exposure
Drug: Ziprasidone
Drug: aripiprazole, quetiapine, or risperidone
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Official Title: 1/2-MC4R Genotype and Pediatric Antipsychotic Drug- Induced Weight Gain

Resource links provided by NLM:


Further study details as provided by North Shore Long Island Jewish Health System:

Primary Outcome Measures:
  • weight change [ Time Frame: baseline to week 12 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • percent weight change compared to baseline weight, BMI z-scores and BMI percentiles [ Time Frame: baseline to week 12 ] [ Designated as safety issue: No ]

Estimated Enrollment: 80
Study Start Date: April 2013
Estimated Study Completion Date: April 2014
Estimated Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Ziprasidone
(20-160mg/d, bid) for 12 weeks
Drug: Ziprasidone
random assignment to ZIP (20-160mg/d, bid dosing)
Other Name: Geodon
Active Comparator: Aripiprazole, quetiapine, risperidone
Aripiprazole (2-30mg/d), Quetiapine (25-800mg/d) or Risperidone (0.1-8mg/d) for 12 weeks
Drug: aripiprazole, quetiapine, or risperidone
random assignement to Usual Care antipsychotic UC antipsychotic (aripiprazole 2-30mg/d, quetiapine 25-800mg/d or risperidone 0.1-8mg/d)
Other Name: Abilify, Seroquel, Risperdal

  Eligibility

Ages Eligible for Study:   13 Years to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01844700

Contacts
Contact: Anil Malhotra, MD. 718-470-8012 malhotra@lij.edu

Locations
United States, New York
Zucker Hillside Hospital, Psychiatry Research Not yet recruiting
Glen Oaks, New York, United States, 11004
Contact: Anil Malhotra, M.D.    718-470-8012    malhotra@lij.edu   
Contact: Christoph Correll, M.D.    718-470-4812    ccorrell@lij.edu   
Principal Investigator: Anil Malhotra, M.D.         
Sponsors and Collaborators
North Shore Long Island Jewish Health System
  More Information

Publications:
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Findling RL, Cavus I, Pappadopulos E, Bachinsly M, Schwartz J, Vanderburg D. Efficacy and safety of ziprasidone in adolescents with schizophrenia. Presented at the 2nd Bi-annual Meeting of the Schizophrenia International Research Society (SIRS), April 10-14, 2010, Venice, Italy.
Guy W. ECDEU Assessment Manual for Psychopharmacology, revised, 1976 Vol DHEW Pub. No. (ADM) 76-338. Rockville, MD: National Institute of Mental Health.
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Psychological Corporation (1999): Wechsler Abbreviated Scale of Intelligence (WASI) manual. San-Antonio, Tx.
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Responsible Party: Anil K. Malhotra, Director, Psychiatric Research, North Shore Long Island Jewish Health System
ClinicalTrials.gov Identifier: NCT01844700     History of Changes
Other Study ID Numbers: NOT-MH-12-014
Study First Received: April 29, 2013
Last Updated: April 30, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by North Shore Long Island Jewish Health System:
MC4R genotype
antipsychotic induced weight gain
pediatric population

Additional relevant MeSH terms:
Body Weight Changes
Weight Gain
Body Weight
Signs and Symptoms
Antipsychotic Agents
Aripiprazole
Quetiapine
Risperidone
Ziprasidone
Central Nervous System Agents
Central Nervous System Depressants
Dopamine Agents
Dopamine Antagonists
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Pharmacologic Actions
Physiological Effects of Drugs
Psychotropic Drugs
Serotonin Agents
Serotonin Antagonists
Therapeutic Uses
Tranquilizing Agents

ClinicalTrials.gov processed this record on July 05, 2015