Autistic DisorderNCT00027404
Study of Fluoxetine in Adults With Autistic Disorder
A study testing Fluoxetine in people with Autistic Disorder, run by Icahn School of Medicine at Mount Sinai at 1 site in United States.
Trial summary
This is a study to determine the effect of fluoxetine in the treatment of adult autism and on functional ability and behavior associated with autism. Evidence suggests abnormal serotonin function in autism. Fluoxetine is a selective inhibitor of the serotonin transporter. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Autistic Disorder
- What is being tested?
- Fluoxetine
- How many people
- 48 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2001to Aug 2005
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Meets DSM-IV and ADI criteria for autistic disorder
- Patients must use effective contraception
- Negative pregnancy test
- Clinical Global Impression-Severity Scale for Autistic Disorder (CGI-AD) score of 4
Who cannot join
- Pregnant or nursing
- Prior or concurrent history of mental disorders, including schizophrenia, schizoaffective disorder, organic mental disorders, or bipolar disorders
- Concurrent depression determined by DSM-IV diagnosis
- Serious suicidal risk
- Active seizure disorder within the past 2 years
- Clinically significant or unstable medical illness, including hematopoietic or cardiovascular disease
Show all 27Show fewer
- Any organic or systemic disease
- Any geographical condition that would preclude study compliance
- Prior or concurrent gastrointestinal, liver, or kidney disease
- Any other concurrent condition that interferes with the absorption, distribution, metabolism, or excretion of drugs
- Prior or concurrent cerebrovascular disease or brain trauma
- Prior or concurrent clinically significant unstable endocrine disorder, such as hypo- or hyperthyroidism
- Prior or concurrent malignancy
- Clinically significant abnormalities on EKG, laboratory tests, or physical exam
- Requirement for ECT or any other psychotropic medication
- Inability to tolerate taper from psychoactive medication
- History of hypersensitivity or severe side effects associated with the use of fluoxitine or other serotonin reuptake inhibitors
- Treatment with any drug known to have a well-defined potential for toxicity to a major organ within the past 30 days
- Concurrent terfenadine (Seldane) or astemizole (Hismanal)
- Prior treatment with fluoxetine of 40 mg/day for 6 weeks
- Prior electroconvulsive therapy within the past 3 months
- Prior investigational drug use within the past 30 days
- Prior Monoamine oxidase inhibitor use within the past 14 days
- Prior long-acting phenothiazines within the past 6 weeks
- Prior psychotropic drugs within the past 7 days
- Prior fluoxetine within the past 6 weeks
- Requirement for any therapeutic intervention that would confound study evaluation
Trial locations and contacts
1 site in 1 country.
United States1 site
Mount Sinai School of Medicine
New York, New York, 10029
About this study
Official title: Fluoxetine vs Placebo in Adult Autistic Disorder
This is a study to determine the effect of fluoxetine in the treatment of adult autism and on functional ability and behavior associated with autism. Evidence suggests abnormal serotonin function in autism. Fluoxetine is a selective inhibitor of the serotonin transporter.
Read the detailed description
Eligible patients will undergo comprehensive evaluation. Informants familiar with the patient will also provide information. Patients will be randomized to receive treatment or placebo. During the 12-week treatment there will be weekly monitoring for the first 4 weeks and biweekly monitoring for the next 8 weeks. The drug dosage will be increased each week as tolerated by the patient. Serum levels of fluoxetine and norfluoxetine will be documented at Week 12.
Completion date provided represents the completion date of the grant per OOPD records
- Conditions
- Autistic Disorder
- Being tested
- Fluoxetine
- Keywords
- Adult, Autism
- Medical subject headings
- Autistic Disorder
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 posted7 Dec 2001 (estimated)
- Study startSep 2001
- Study completionAug 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Autistic DisorderStudies 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
- Parallel groups
- Masking
- Double blind
- Enrolment
- 48 participants
Sponsor and investigators
- Lead sponsor
- Icahn School of Medicine at Mount Sinai
- Sponsor type
- University, hospital or other
- Investigators
- Eric Hollander, MD, Principal investigator, Mount Sinai School of Medicine New York, New York, United States
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00027404
- Sponsor's protocol ID
- FD-R-2026-01
- Other IDs
- FD-R-002026-01
- Status last verified
- Nov 2002
- First submitted
- 5 Dec 2001
- Last updated
- 25 Mar 2015
- Results posted
- No
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
- Fluoxetine vs Placebo in Adult Autistic Disorder
- ClinicalTrials.gov ID
- NCT00027404
- Acronym / sponsor ID
- FD-R-2026-01
- Conditions
- Autistic Disorder
- Keywords
- Adult, Autism
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants
- Lead sponsor
- Icahn School of Medicine at Mount SinaiUniversity, hospital or other
- Study start
- Sep 2001
- Study completion
- Aug 2005
- First posted
- 7 Dec 2001 (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 study to determine the effect of fluoxetine in the treatment of adult autism and on functional ability and behavior associated with autism. Evidence suggests abnormal serotonin function in autism. Fluoxetine is a selective inhibitor of the serotonin transporter.
Detailed description
Eligible patients will undergo comprehensive evaluation. Informants familiar with the patient will also provide information. Patients will be randomized to receive treatment or placebo. During the 12-week treatment there will be weekly monitoring for the first 4 weeks and biweekly monitoring for the next 8 weeks. The drug dosage will be increased each week as tolerated by the patient. Serum levels of fluoxetine and norfluoxetine will be documented at Week 12.
Completion date provided represents the completion date of the grant per OOPD records
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Meets DSM-IV and ADI criteria for autistic disorder
- Patients must use effective contraception
- Negative pregnancy test
- Clinical Global Impression-Severity Scale for Autistic Disorder (CGI-AD) score of 4
Key exclusion criteria (27 listed)
- Pregnant or nursing
- Prior or concurrent history of mental disorders, including schizophrenia, schizoaffective disorder, organic mental disorders, or bipolar disorders
- Concurrent depression determined by DSM-IV diagnosis
- Serious suicidal risk
- Active seizure disorder within the past 2 years
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.
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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, MD principal investigator
Mount Sinai School of Medicine New York, New York, United States
1 site 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 Autistic Disorder, run by Icahn School of Medicine at Mount Sinai 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 27 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. 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?
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.