AutismPhase 2/3NCT00183404
Long-Term Olanzapine Treatment in Children With Autism
A Phase 2/3 study testing Olanzapine in people with Autism, run by Drexel University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 3 to 12 years
- Conditions the study is for
- Autism
- What is being tested?
- Olanzapine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2004to Oct 2011
- Phase
- Phase 2/3
- 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
- Diagnosis of autism
- Parent or guardian willing to provide informed consent
Who cannot join
- Uncontrolled seizure disorder
- Medical illness other than autism affecting the whole body
- Obesity
- History of psychosis
- Impairment of voluntary movement
- History of olanzapine treatment
Trial locations and contacts
1 site in 1 country.
United States1 site
Drexel University College of Medicine at Friends Hospital
Philadelphia, Pennsylvania, 19124
About this study
This study will determine the short- and long-term safety and effectiveness of the drug olanzapine (Zyprexa®) for reducing symptoms of autism in children.
Read the detailed description
Autism is a serious childhood disorder that can significantly impair functioning and development. Educational and psychosocial programs are standard treatments for autistic children, but drug therapy is often needed as well. Haloperidol is the drug most commonly prescribed for symptoms of autism. However, long-term administration of haloperidol has been associated with adverse effects such as blurred vision, constipation, and nausea. The investigation of alternative drug treatments is necessary. This study will determine whether the antipsychotic drug olanzapine may be a safe and effective alternative to haloperidol for treating symptoms of autism in children.
This study will last 36 weeks and will comprise 2 phases. In Phase I, participants will be randomly assigned to receive either olanzapine or placebo for 12 weeks. Participants who do not respond to treatment will complete their participation in the study. Participants who respond to their assigned Phase I treatment will continue onto Phase II. All Phase II participants will receive olanzapine daily for 6 months. Self-report scales and checklists will be used to assess participants after each phase; these measures will be completed by participants and their parents.
- Conditions
- Autism
- Being tested
- Olanzapine
- Keywords
- Drug Treatment, Child, Olanzapine
- Medical subject headings
- Autistic Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OlanzapineDrug
Also called Open Olanzapine
Olanzapine tablets, dosed once or twice per day, dosage 2.5 to 20 mg per day
| Study group | Role | What they receive |
|---|---|---|
| Olanzapine | Experimental | Participants will take open olanzapine for up to 20 additional weeks after phase 1. Receives: Drug: Olanzapine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Children's Psychiatric Rating Scale
Measured: Measured monthly throughout the study
Secondary outcomes (6)
Aberrant Behavior Checklist
Measured: Measured monthly throughout the study
Clinical Global Impressions
Measured: Measured monthly throughout the study
Treatment Emergent Symptoms Scale
Measured: Measured monthly throughout the study
Olanzapine Untoward Effects Checklist
Measured: Measured monthly throughout the study
Abnormal Involuntary Movement Scale
Measured: Measured monthly throughout the study
Neurological Rating Scale
Measured: Measured monthly throughout the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2005 (estimated)
- Study startSep 2004
- Primary completionJul 2011
- Study completionOct 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AutismStudies 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 2/3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Drexel University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Sponsor
- Investigators
- Richard P. Malone, MD, Principal investigator, Drexel University College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00183404
- Sponsor's protocol ID
- R01MH073524
- Other IDs
- R01MH073524, DDTR B2-NDA
- Status last verified
- Aug 2014
- First submitted
- 13 Sep 2005
- Last updated
- 15 Aug 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long-Term Olanzapine Treatment in Children With Autism
- ClinicalTrials.gov ID
- NCT00183404
- Acronym / sponsor ID
- R01MH073524
- Conditions
- Autism
- Keywords
- Drug Treatment, Child, Olanzapine
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Drexel UniversityUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- Sep 2004
- Primary completion
- Jul 2011 (actual)
- Study completion
- Oct 2011 (actual)
- First posted
- 16 Sep 2005 (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 study will determine the short- and long-term safety and effectiveness of the drug olanzapine (Zyprexa®) for reducing symptoms of autism in children.
Detailed description
Autism is a serious childhood disorder that can significantly impair functioning and development. Educational and psychosocial programs are standard treatments for autistic children, but drug therapy is often needed as well. Haloperidol is the drug most commonly prescribed for symptoms of autism. However, long-term administration of haloperidol has been associated with adverse effects such as blurred vision, constipation, and nausea. The investigation of alternative drug treatments is necessary. This study will determine whether the antipsychotic drug olanzapine may be a safe and effective alternative to haloperidol for treating symptoms of autism in children.
This study will last 36 weeks and will comprise 2 phases. In Phase I, participants will be randomly assigned to receive either olanzapine or placebo for 12 weeks. Participants who do not respond to treatment will complete their participation in the study. Participants who respond to their assigned Phase I treatment will continue onto Phase II. All Phase II participants will receive olanzapine daily for 6 months. Self-report scales and checklists will be used to assess participants after each phase; these measures will be completed by participants and their parents.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Olanzapine | Experimental | Drug: OlanzapineParticipants will take open olanzapine for up to 20 additional weeks after phase 1. |
Who may qualify
- Ages
- 3 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Diagnosis of autism
- Parent or guardian willing to provide informed consent
Key exclusion criteria (6 listed)
- Uncontrolled seizure disorder
- Medical illness other than autism affecting the whole body
- Obesity
- History of psychosis
- Impairment of voluntary movement
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 |
|---|---|---|
| OlanzapineAlso: Open OlanzapineOlanzapine tablets, dosed once or twice per day, dosage 2.5 to 20 mg per day | Drug | Olanzapine |
Primary outcome
Children's Psychiatric Rating Scale
Time frame: Measured monthly throughout the study
6 secondary outcomes
Aberrant Behavior Checklist
Time frame: Measured monthly throughout the study
Clinical Global Impressions
Time frame: Measured monthly throughout the study
Treatment Emergent Symptoms Scale
Time frame: Measured monthly throughout the study
Olanzapine Untoward Effects Checklist
Time frame: Measured monthly throughout the study
Abnormal Involuntary Movement Scale
Time frame: Measured monthly throughout the study
Neurological Rating Scale
Time frame: Measured monthly throughout the study
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 15 Aug 2014.
Related trials for Autism
RecruitingPhase 1
Cannabidiol (CBD) in Adults With ASD
Autism Spectrum Disorder
RecruitingPhase 3
A Study to Evaluate the Long-term Safety and Tolerability of Xanomeline and Trospium Chloride for the Treatment of Psychiatric Disorders in Children and Adolescents
Schizophrenia, Autism-Related Irritability
Not yet recruiting
Sensory-integration Therapy Verses Augumented Reality-based Training in ASD
Autism Spectrum Disorder
Recruiting
Cumulative and Booster Effects of Multisession Prefrontal tDCS in ASD Adolescents
Transcranial Direct Current Stimulation, Autistic Spectrum Disorder
Not yet recruiting
"Family Resilience And Mind-body Enhancement" (FRAME): A Randomised Controlled Trial
Autism
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 2/3 study testing Olanzapine in people with Autism, run by Drexel University 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 2 inclusion and 6 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 15 Aug 2014. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined 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.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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: Measured monthly throughout the study). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 15 Aug 2014.