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

January 6, 2016 updated by: Anil K. Malhotra, Northwell Health
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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

14

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • Glen Oaks, New York, United States, 11004
        • Zucker Hillside Hospital, Psychiatry Research

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

13 years to 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Ziprasidone
(20-160mg/d, bid) for 12 weeks
Drug: Ziprasidone
random assignment to ZIP (20-160mg/d, bid dosing)
Other Names:
  • 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 Names:
  • Abilify, Seroquel, Risperdal

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Weight Change
Time Frame: baseline to week 12
baseline to week 12

Secondary Outcome Measures

Outcome Measure
Time Frame
Percent Weight Change Compared to Baseline Weight
Time Frame: baseline to week 12
baseline to week 12
BMI Z-scores
Time Frame: baseline to week 12
baseline to week 12
BMI Percentile
Time Frame: baseline to week 12
baseline to week 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Northwell Health

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2013

Primary Completion (Actual)

April 1, 2014

Study Completion (Actual)

April 1, 2014

Study Registration Dates

First Submitted

April 29, 2013

First Submitted That Met QC Criteria

April 30, 2013

First Posted (Estimate)

May 1, 2013

Study Record Updates

Last Update Posted (Estimate)

February 5, 2016

Last Update Submitted That Met QC Criteria

January 6, 2016

Last Verified

January 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 12-403A

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on High Risk MC4R Genotype

Clinical Trials on Ziprasidone

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Congo

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe