Autistic DisorderPhase 2NCT00057408
A Controlled Study of Olanzapine in Children With Autism
A Phase 2 study testing olanzapine (Zyprexa) in people with Autistic Disorder, run by FDA Office of Orphan Products Development at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 3 to 12 years
- Conditions the study is for
- Autistic Disorder
- What is being tested?
- olanzapine (Zyprexa)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 78 participants
- Where
- 1 siteUnited States
- Study dates
- May 2003to Sep 2005
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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).
Trial locations and contacts
1 site in 1 country.
United States1 site
Drexel University College of Medicine c/o Friends Hospital
Philadelphia, Pennsylvania, 19124
About this study
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.
- Conditions
- Autistic Disorder
- Being tested
- olanzapine (Zyprexa), Placebo
- Keywords
- Autism, Pervasive Developmental Disorder, Treatment, Olanzapine, Antipsychotic
- Medical subject headings
- Autistic Disorder, Child Development Disorders, Pervasive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
olanzapine (Zyprexa)Drug
Also called Antipsychotic Drug
Olanzapine tablets given po at a dosage of 2.5 - 20 mg per day for up to 12 weeks.
PlaceboDrug
Also called Placebo controlled
Matching Placebo
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Treatment with olanzapine Receives: Drug: olanzapine (Zyprexa) |
| 2 | Placebo comparator | Matching placebo treatment Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Children's Psychiatric Rating Scale
Measured: Weekly
Secondary outcomes (6)
Clinical Global Impressions
Measured: Weekly
Aberant Behavior Checklist
Measured: Weekly
Treatment Emergent Symptoms Scale
Measured: Weekly
Olanzapine Untoward Effects Checklist
Measured: Weekly
Abnormal Involuntary Movement Scale
Measured: Weekly
Neurological Rating Scale
Measured: Weekly
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2003 (estimated)
- Study startMay 2003
- Study completionSep 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Autistic DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 78 participants (estimated)
Sponsor and investigators
- Lead sponsor
- FDA Office of Orphan Products Development
- Sponsor type
- US federal agency
- Collaborators
- National Institute of Mental Health (NIMH)
- Investigators
- Richard P Malone, MD, Principal investigator, Drexel University College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00057408
- Sponsor's protocol ID
- 2190
- Status last verified
- Sep 2011
- First submitted
- 1 Apr 2003
- Last updated
- 25 Mar 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 37811711
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Controlled Study of Olanzapine in Children With Autism
- ClinicalTrials.gov ID
- NCT00057408
- Acronym / sponsor ID
- 2190
- Conditions
- Autistic Disorder
- Keywords
- Autism, Pervasive Developmental Disorder, Treatment, Olanzapine, Antipsychotic
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 78 participants (estimated)
- Lead sponsor
- FDA Office of Orphan Products DevelopmentUS federal agency
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- May 2003
- Study completion
- Sep 2005
- First posted
- 2 Apr 2003 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: olanzapine (Zyprexa)Treatment with olanzapine |
| 2 | Placebo comparator | Drug: PlaceboMatching placebo treatment |
Who may qualify
- Ages
- 3 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (12 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| olanzapine (Zyprexa)Also: Antipsychotic DrugOlanzapine tablets given po at a dosage of 2.5 - 20 mg per day for up to 12 weeks. | Drug | 1 |
| PlaceboAlso: Placebo controlledMatching Placebo | Drug | 2 |
Primary outcome
Children's Psychiatric Rating Scale
Time frame: Weekly
6 secondary outcomes
Clinical Global Impressions
Time frame: Weekly
Aberant Behavior Checklist
Time frame: Weekly
Treatment Emergent Symptoms Scale
Time frame: Weekly
Olanzapine Untoward Effects Checklist
Time frame: Weekly
Abnormal Involuntary Movement Scale
Time frame: Weekly
Neurological Rating Scale
Time frame: Weekly
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2015.
- Derived from this study: PubMed 37811711Iffland 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Richard P Malone, MD principal investigator
Drexel University College of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing olanzapine (Zyprexa) in people with Autistic Disorder, run by FDA Office of Orphan Products Development at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Children's Psychiatric Rating Scale (time frame: Weekly). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00057408, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Mar 2015.