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Treatment of Overweight Induced by Antipsychotic Medication in Young People With Autism Spectrum Disorders (ASD) (MET)

25. januar 2018 oppdatert av: Evdokia Anagnostou
The purpose of this study is to determine whether metformin is safe and effective in the treatment of weight or weight gain in young people with Autism Spectrum Disorders (ASD) who are currently taking atypical antipsychotic medication.

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

This is a double-blind, placebo-controlled, multi-site randomized trial to evaluate oral fixed dose metformin (Riomet®) in decreasing weight or weight gain in children ages 6-17 years, 4 months with ASD who are currently taking atypical antipsychotic medication. A 16-week, double-blind, placebo-controlled randomized trial of metformin with dose guided by age will be conducted. A secondary study aim will be to assess the long-term safety and efficacy of metformin by conducting a 16-week open label continuation.

Studietype

Intervensjonell

Registrering (Faktiske)

60

Fase

  • Fase 3

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M4G 1R8
        • Holland Bloorview Kids Rehabilitation Hospital
  • Forente stater
    • Ohio
      • Columbus, Ohio, Forente stater, 43210
        • Ohio State University/Nationwide Children's Hospital
    • Pennsylvania
      • Pittsburgh, Pennsylvania, Forente stater, 15203
        • University of Pittsburgh Medical Center
    • Tennessee
      • Nashville, Tennessee, Forente stater, 37212
        • Vanderbilt University

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

6 år til 17 år (Barn)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

Inclusion Criteria:

  1. Diagnosis of Autism Spectrum Disorder (autistic disorder, pervasive developmental disorder not otherwise specified), Asperger's disorder) based upon an Autism Diagnostic Observation Scale (ADOS) and Diagnostic and Statistical Manual (DSM-IV) interview.
  2. Minimum of 1 month on a stable atypical antipsychotic dose with no plans to change the dose for the next 4 months.
  3. A documented greater than/equal to 7% increase in BMI since starting atypical antipsychotic therapy(going back as far as prior 12 months); or, if BMI is greater or equal to 85th percentile corrected for age and sex, then a greater than 5% body weight increase per year (prorated at greater than 5% body weight increase if medicated for longer than a year).
  4. Age 6 years to 17 years, 4 months.
  5. Subjects and their parents (guardians) must be judged reliable for medication compliance and must agree to keep appointments for study visits and tests as outlined in the protocol.
  6. Prior to the conduct of any study-specific procedures, the subject must provide assent to participate in the study (if developmentally appropriate), and their parents (guardians) must provide written informed consent.

Exclusion Criteria:

  1. History of intolerable adverse effects with metformin.
  2. Prior history of an exposure to metformin of sufficient dose or duration to determine response status.
  3. History of liver disease, renal impairment, congestive heart failure, pernicious anemia, any other condition increasing the risk for lactic acidosis, or any serious medical illness requiring treatment.
  4. Use of cationic drugs excreted by the kidneys.
  5. Planned surgery or procedure requiring contrast.
  6. Pregnant at screening contact.
  7. On other psychotropic concomitant medications for less than 2 months.
  8. Treatment or planned treatment with concomitant medications with unacceptable interactions with metformin, including topiramate, levetiracetam, beta blockers, angiotensin-converting-enzyme (ACE) inhibitors, diuretics, or histamine H2 receptor antagonists.
  9. Unable to tolerate blood work.
  10. Current use of medication for target symptoms of appetite or weight loss.
  11. Planned change of medication, medication dose, or behavioral treatment targeting weight loss during the study period.

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Firemannsrom

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: Metformin
Legemiddel: Metformin
Metformin will be dispensed in a liquid suspension of 100 mg/mL. For children 6-9 years of age, metformin will be started at 250 mg at their evening meal for 1 week, followed by the addition of a 250 mg dose at breakfast for 1 week. At the Week 2 visit, if metformin is well-tolerated, the dose will be increased to 500 mg twice daily. For children from 10-17 years of age, metformin will be started at 250 mg at their evening meal for 1 week, followed by the addition of a 250 mg dose at breakfast for 1 week. At the Week 2 visit, if metformin is well-tolerated, the dose will be increased to 500 mg twice daily. At the Week 4 visit, if metformin is well-tolerated, the dose will be increased to 850 mg twice daily.
Andre navn:
  • Riomet
Placebo komparator: Placebo Hydrochloride Oral Solution
Legemiddel: Placebo
The placebo hydrochloride oral solution will be prepared to match the appearance, smell and taste of the metformin as closely as possible. For children from 6-9 years of age, placebo will be started at 250 mg at their evening meal for 1 week, followed by the addition of a 250 mg dose at breakfast for 1 week. At the Week 2 visit, if placebo is well-tolerated, the dose will be increased to 500 mg twice daily. For children from 10-17 years of age, placebo will be started at 250 mg at their evening meal for 1 week, followed by the addition of a 250 mg dose at breakfast for 1 week. At the Week 2 visit, if placebo is well-tolerated, the dose will be increased to 500 mg twice daily. At the Week 4 visit, if placebo is well-tolerated, the dose will be increased to 850 mg twice daily.

Hva måler studien?

Primære resultatmål

Resultatmål
Tidsramme
Change in Body Mass Index Z-score
Tidsramme: Baseline, 16 Weeks
Baseline, 16 Weeks

Sekundære resultatmål

Resultatmål
Tidsramme
Changes in Additional Body Composition Parameters (Absolute Change in Weight)
Tidsramme: Baseline, 16 Weeks
Baseline, 16 Weeks
Changes in Additional Body Composition Parameters (Relative Change in Weight)
Tidsramme: Baseline, 16 Weeks
Baseline, 16 Weeks
Changes in Additional Body Composition Parameters (Absolute BMI)
Tidsramme: Baseline, 16 Weeks
Baseline, 16 Weeks
Changes in Additional Body Composition Parameters (Abdominal Circumference)
Tidsramme: Baseline, 16 Weeks
Baseline, 16 Weeks
Changes in Additional Body Composition Parameters (Hip Circumference)
Tidsramme: Baseline, 16 Weeks
Baseline, 16 Weeks
Changes in Fasting Metabolic Parameters (Total Cholesterol)
Tidsramme: Baseline, 16 Weeks
Baseline, 16 Weeks
Changes in Fasting Metabolic Parameters (LDL)
Tidsramme: Baseline, 16 Weeks
Baseline, 16 Weeks
Changes in Fasting Metabolic Parameters (HDL)
Tidsramme: Baseline, 16 Weeks
Baseline, 16 Weeks
Changes in Fasting Metabolic Parameters (Triglycerides)
Tidsramme: Baseline, 16 Weeks
Baseline, 16 Weeks
Changes in Fasting Metabolic Parameters (Glucose)
Tidsramme: Baseline, 16 Weeks
Baseline, 16 Weeks
Changes in Fasting Metabolic Parameters (Insulin)
Tidsramme: Baseline, 16 Weeks
Baseline, 16 Weeks

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Evdokia Anagnostou

Samarbeidspartnere

Massachusetts General Hospital
University of Pittsburgh
Vanderbilt University
Ohio State University
Nationwide Children's Hospital

Etterforskere

  • Hovedetterforsker: Evdokia Anagnostou, M.D., Holland Bloorview Kids Rehabilitation Hospital
  • Hovedetterforsker: Jeremey Veenstra-VanderWeele, M.D., Columbia University
  • Hovedetterforsker: Benjamin Handen, Ph.D., University of Pittsburgh Medical Center
  • Hovedetterforsker: Michael Aman, Ph.D., Ohio State University/Nationwide Children's Hospital
  • Hovedetterforsker: Eric Butter, Ph.D., Nationwide Children's Hospital
  • Hovedetterforsker: Kevin Sanders, M.D., Vanderbilt University

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Generelle publikasjoner

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart

1. april 2013

Primær fullføring (Faktiske)

1. juni 2015

Studiet fullført (Faktiske)

1. oktober 2015

Datoer for studieregistrering

Først innsendt

7. februar 2013

Først innsendt som oppfylte QC-kriteriene

5. april 2013

Først lagt ut (Anslag)

8. april 2013

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

22. februar 2018

Siste oppdatering sendt inn som oppfylte QC-kriteriene

25. januar 2018

Sist bekreftet

1. januar 2018

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • MET-10-2012

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