NCT00183404

Brief Summary

This study will determine the short- and long-term safety and effectiveness of the drug olanzapine (Zyprexa®) for reducing symptoms of autism in children.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
32

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Sep 2004

Longer than P75 for phase_2

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2004

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

September 13, 2005

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 16, 2005

Completed
5.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2011

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2011

Completed
Last Updated

August 15, 2014

Status Verified

August 1, 2014

Enrollment Period

6.8 years

First QC Date

September 13, 2005

Last Update Submit

August 14, 2014

Conditions

Autism

Keywords

Drug TreatmentChildOlanzapine

Outcome Measures

Primary Outcomes (1)

  • Children's Psychiatric Rating Scale

    Measured monthly throughout the study

Secondary Outcomes (6)

  • Aberrant Behavior Checklist

    Measured monthly throughout the study

  • Clinical Global Impressions

    Measured monthly throughout the study

  • Treatment Emergent Symptoms Scale

    Measured monthly throughout the study

  • Olanzapine Untoward Effects Checklist

    Measured monthly throughout the study

  • Abnormal Involuntary Movement Scale

    Measured monthly throughout the study

  • +1 more secondary outcomes

Study Arms (1)

Olanzapine

EXPERIMENTAL

Participants will take open olanzapine for up to 20 additional weeks after phase 1.

Drug: Olanzapine

Interventions

OlanzapineDRUG

Olanzapine tablets, dosed once or twice per day, dosage 2.5 to 20 mg per day

Also known as: Open Olanzapine
Olanzapine

Eligibility Criteria

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

You may qualify if:

  • Diagnosis of autism
  • Parent or guardian willing to provide informed consent

You may not qualify if:

  • Uncontrolled seizure disorder
  • Medical illness other than autism affecting the whole body
  • Obesity
  • History of psychosis
  • Impairment of voluntary movement
  • History of olanzapine treatment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Drexel University College of Medicine at Friends Hospital

Philadelphia, Pennsylvania, 19124, United States

Location

MeSH Terms

Conditions

Autistic Disorder

Interventions

Olanzapine

Condition Hierarchy (Ancestors)

Autism Spectrum DisorderChild Development Disorders, PervasiveNeurodevelopmental DisordersMental Disorders

Intervention Hierarchy (Ancestors)

BenzodiazepinesBenzazepinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • Richard P. Malone, MD

    Drexel University College of Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 13, 2005

First Posted

September 16, 2005

Study Start

September 1, 2004

Primary Completion

July 1, 2011

Study Completion

October 1, 2011

Last Updated

August 15, 2014

Record last verified: 2014-08

Locations

US(1)