NCT00057408

Brief Summary

This is a 12-week study which investigates the use of olanzapine to decrease disruptive behaviors sometimes associated with Autism in children, aged 3 to 12 years old. The first six weeks of the study are double-blind and placebo controlled, meaning that patients receive either placebo or olanzapine, and that neither the researchers nor the patients know whether or not they are receiving placebo or olanzapine. In the second six weeks all of the patients receive olanzapine. The purpose in using placebo is that it is otherwise impossible to know how effective the drug is or whether or not the drug causes side effects. Patients treated with placebo can have improvement and can have side effects. In the study patients receive a psychiatric evaluation, physical examination, laboratory tests, and study medication (olanzapine or placebo), free of charge.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
78

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started May 2003

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 1, 2003

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 2, 2003

Completed
29 days until next milestone

Study Start

First participant enrolled

May 1, 2003

Completed
2.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2005

Completed
Last Updated

March 25, 2015

Status Verified

September 1, 2011

First QC Date

April 1, 2003

Last Update Submit

March 24, 2015

Conditions

Autistic Disorder

Keywords

AutismPervasive Developmental DisorderTreatmentOlanzapineAntipsychotic

Outcome Measures

Primary Outcomes (1)

  • Children's Psychiatric Rating Scale

    Weekly

Secondary Outcomes (6)

  • Clinical Global Impressions

    Weekly

  • Aberant Behavior Checklist

    Weekly

  • Treatment Emergent Symptoms Scale

    Weekly

  • Olanzapine Untoward Effects Checklist

    Weekly

  • Abnormal Involuntary Movement Scale

    Weekly

  • +1 more secondary outcomes

Study Arms (2)

1

EXPERIMENTAL

Treatment with olanzapine

Drug: olanzapine (Zyprexa)

2

PLACEBO COMPARATOR

Matching placebo treatment

Drug: Placebo

Interventions

olanzapine (Zyprexa)DRUG

Olanzapine tablets given po at a dosage of 2.5 - 20 mg per day for up to 12 weeks.

Also known as: Antipsychotic Drug
1
PlaceboDRUG

Matching Placebo

Also known as: Placebo controlled
2

Eligibility Criteria

Age3 Years - 12 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Males and females, Aged between 3 and 12 years.
  • Autistic disorder - DSM-IV criteria.
  • A score of at least moderately impaired on the CGI-Severity item.
  • Clinical judgment that medication treatment for autism is indicated.

You may not qualify if:

  • Rett's disorder, childhood disintegrative disorder, Asperger's disorder, and PDD, NOS.
  • Psychotic disorder (DSM-IV) (including schizophreniform disorder and schizophrenia).
  • Major depressive disorder (DSM-IV).
  • Bipolar disorder (DSM-IV).
  • History of psychoactive drug in the previous 2 weeks prior to phase 1.
  • A history of treatment with olanzapine for a cumulative period of greater than 2 weeks prior to entering phase 1.
  • Systemic diseases such as cardiac, renal, thyroid diseases, uncontrolled seizure disorder (seizure disorder that is not controlled by anti-epileptic medication - a child who is seizure free for a period of 6 months on a stable dose of antiepileptic drug would be considered controlled), or diabetes mellitus.
  • Children with a known medical cause for autistic disorder.
  • Abnormal fasting blood glucose or history of diabetes.
  • Baseline body mass index (BMI) greater than the 90th percentile for age and gender (CDC growth charts, Kuczmarski et al, 2000) (because of risk of weight gain).
  • Baseline QTc \>450 msec. Note: Historically, patients we evaluate do not have QTc values \>450.
  • Dyskinesias at baseline (per the criteria of Schooler and Kane, 1982).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Drexel University College of Medicine c/o Friends Hospital

Philadelphia, Pennsylvania, 19124, United States

Location

Related Publications (1)

  • Iffland M, Livingstone N, Jorgensen M, Hazell P, Gillies D. Pharmacological intervention for irritability, aggression, and self-injury in autism spectrum disorder (ASD). Cochrane Database Syst Rev. 2023 Oct 9;10(10):CD011769. doi: 10.1002/14651858.CD011769.pub2.

    PMID: 37811711DERIVED

MeSH Terms

Conditions

Autistic DisorderChild Development Disorders, Pervasive

Interventions

OlanzapineAntipsychotic Agents

Condition Hierarchy (Ancestors)

Autism Spectrum DisorderNeurodevelopmental DisordersMental Disorders

Intervention Hierarchy (Ancestors)

BenzodiazepinesBenzazepinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsTranquilizing AgentsCentral Nervous System DepressantsPhysiological Effects of DrugsPharmacologic ActionsChemical Actions and UsesCentral Nervous System AgentsTherapeutic UsesPsychotropic Drugs

Study Officials

  • Richard P Malone, MD

    Drexel University College of Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
FED

Study Record Dates

First Submitted

April 1, 2003

First Posted

April 2, 2003

Study Start

May 1, 2003

Study Completion

September 1, 2005

Last Updated

March 25, 2015

Record last verified: 2011-09

Locations

US(1)