AutismNCT00004486
Randomized Study of Fluoxetine in Children and Adolescents With Autism
A study testing fluoxetine in people with Autism, run by Icahn School of Medicine at Mount Sinai at 3 sites in United States.
Trial summary
OBJECTIVES: I. Evaluate the efficacy of fluoxetine on social and language deficits, global severity and compulsive dimensions of children and adolescents with autism. II. Assess the effectiveness of this treatment regimen on neurocognitive deficits in this patient population. III. Read more about this study
- Who is it for?
- Ages 5 to 17 years
- Conditions the study is for
- Autism
- What is being tested?
- fluoxetine
- How many people
- 45 participants
- Where
- 3 sitesUnited States
- Study dates
- Sep 1998to Dec 2002
- Phase
- Interventional
- 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 5 to 17 years
- All sexes
- No healthy volunteers
- Child
PROTOCOL ENTRY CRITERIA:
--Disease Characteristics--
Meets diagnostic criteria for autism
--Prior/Concurrent Therapy--
Other:
- At least 3 months since prior electroconvulsive therapy
- At least 1 month since prior investigational drugs or treatment with any drug known to cause major organ toxicity
- At least 2 weeks since prior monoamine oxidase inhibitors
- At least 6 weeks since prior long acting phenothiazines
- At least 1 week since prior other psychotropic drugs
- No prior fluoxetine of 20 mg/day for 6 weeks
- At least 6 weeks since prior fluoxetine
- No concurrent use of terfenadine (Seldane) or astemizole (Hismanal)
- No concurrent electroconvulsive therapy or other psychotropic drugs (unless otherwise permitted)
- Prior participation in another serotonin reuptake inhibitor trial allowed
--Patient Characteristics--
Hematopoietic: No significant hematopoietic disease
Hepatic: No prior or concurrent liver disease
Renal: No prior or concurrent kidney disease
Cardiovascular:
- No significant cardiovascular disease
- No abnormal EKG
Neurological:
- No prior seizure disorder or high risk development of seizures
- No prior cerebrovascular disease
- No prior brain trauma
Other:
- Not pregnant or nursing
- Negative pregnancy test
- No unstable major medical illness or systemic disease
- No moderate or severe mental retardation and motor deficits (IQ less than 50)
- No family history of bipolar disorder
- No prior or concurrent other mental disorders (e.g., schizophrenia, schizoaffective, organic, or bipolar disorders)
- No significant autoaggressive behavior or serious suicidal risk
- No prior or concurrent gastrointestinal conditions
- No unstable endocrine disease (e.g., hypo or hyperthyroidism)
- No prior or concurrent malignancy
- Must be able to tolerate tapering of psychoactive medication
- No history of hypersensitivity or severe side effects to fluoxetine or other serotonin reuptake inhibitors
- No history of severe personality disorder or noncompliance
Trial locations and contacts
3 sites in 1 country.
United States3 sites
New York University Medical Center
New York, New York, 10016
Mount Sinai School of Medicine
New York, New York, 10029
Albert Einstein College of Medicine
The Bronx, New York, 10461
About this study
OBJECTIVES: I. Evaluate the efficacy of fluoxetine on social and language deficits, global severity and compulsive dimensions of children and adolescents with autism.
II. Assess the effectiveness of this treatment regimen on neurocognitive deficits in this patient population.
III. Compare the baseline compulsive severity and treatment outcome in these patients.
Read the detailed description
PROTOCOL OUTLINE: This is a randomized, double blind, placebo controlled, crossover study. All patients receive oral placebo daily during week 0.
Patients are randomized to receive either oral fluoxetine or oral placebo daily on weeks 1-8. Patients then crossover to receive treatment on the other arm during weeks 12-20.
Completion date provided represents the completion date of the grant per OOPD records
- Conditions
- Autism
- Being tested
- fluoxetine
- Keywords
- autism, neurologic and psychiatric disorders, rare disease
- Medical subject headings
- Autistic Disorder, Neurologic Manifestations, Mental Disorders, Rare Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
fluoxetineDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 1999 (estimated)
- Study startSep 1998
- Study completionDec 2002
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for AutismStudies of the same condition, open and under way.
- More trials run by Icahn School of Medicine at Mount SinaiThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Enrolment
- 45 participants
Sponsor and investigators
- Lead sponsor
- Icahn School of Medicine at Mount Sinai
- Sponsor type
- University, hospital or other
- Investigators
- Eric Hollander, Study chair, Icahn School of Medicine at Mount Sinai
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00004486
- Sponsor's protocol ID
- 199/14266
- Other IDs
- MTS-FDR001520, MTS-GCO-96-713
- Status last verified
- Dec 2000
- First submitted
- 18 Oct 1999
- Last updated
- 25 Mar 2015
- Results posted
- No
Publications
Hollander E, Phillips A, Chaplin W, Zagursky K, Novotny S, Wasserman S, Iyengar R. A placebo controlled crossover trial of liquid fluoxetine on repetitive behaviors in childhood and adolescent autism. Neuropsychopharmacology. 2005 Mar;30(3):582-9. doi: 10.1038/sj.npp.1300627.
PubMed 15602505Iffland 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
- Randomized Study of Fluoxetine in Children and Adolescents With Autism
- ClinicalTrials.gov ID
- NCT00004486
- Acronym / sponsor ID
- 199/14266
- Conditions
- Autism
- Keywords
- autism, neurologic and psychiatric disorders, rare disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants
- Lead sponsor
- Icahn School of Medicine at Mount SinaiUniversity, hospital or other
- Study start
- Sep 1998
- Study completion
- Dec 2002
- First posted
- 19 Oct 1999 (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.
OBJECTIVES: I. Evaluate the efficacy of fluoxetine on social and language deficits, global severity and compulsive dimensions of children and adolescents with autism.
II. Assess the effectiveness of this treatment regimen on neurocognitive deficits in this patient population.
III. Compare the baseline compulsive severity and treatment outcome in these patients.
Detailed description
PROTOCOL OUTLINE: This is a randomized, double blind, placebo controlled, crossover study. All patients receive oral placebo daily during week 0.
Patients are randomized to receive either oral fluoxetine or oral placebo daily on weeks 1-8. Patients then crossover to receive treatment on the other arm during weeks 12-20.
Completion date provided represents the completion date of the grant per OOPD records
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
Who may qualify
- Ages
- 5 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
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 |
|---|---|---|
| fluoxetine | Drug | – |
Primary outcome
Not reported in the source record.
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.
- Results publication: PubMed 15602505Hollander E, Phillips A, Chaplin W, Zagursky K, Novotny S, Wasserman S, Iyengar R. A placebo controlled crossover trial of liquid fluoxetine on repetitive behaviors in childhood and adolescent autism. Neuropsychopharmacology. 2005 Mar;30(3):582-9. doi: 10.1038/sj.npp.1300627.
- 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.
Eric Hollander study chair
Icahn School of Medicine at Mount Sinai
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing fluoxetine in people with Autism, run by Icahn School of Medicine at Mount Sinai at 3 sites 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?
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 3 sites 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.
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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00004486, which also lists 2 linked publications.
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.