Autistic DisorderPhase 3SOFIANCT00515320
Study of Fluoxetine in Autism
A Phase 3 study testing Fluoxetine in people with Autistic Disorder, run by Neuropharm at 17 sites in United States.
Trial summary
The purpose of this study is to assess the effect of fluoxetine orally dissolving tablets (ODT) on the repetitive behaviors core domain in children and adolescents with Autistic Disorder. Read more about this study
- Who is it for?
- Ages 5 to 17 years
- Conditions the study is for
- Autistic Disorder
- What is being tested?
- Fluoxetine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 158 participants
- Where
- 17 sitesUnited States
- Study dates
- Aug 2007to Jan 2009
- Phase
- Phase 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 5 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Meets DSM-IV criteria for autistic disorder, .
- CYBOCS-PDD score of at least 10 at screening.
Who cannot join
- Diagnosis of Asperger Syndrome or Pervasive Developmental Disorder Not Otherwise Specified, Rett Syndrome, Childhood Disintegrative Disorder.
- Patients planning to commence cognitive behaviour therapy during the period of the study or those who have begun cognitive behaviour therapy within 8 weeks prior to enrolment.
- Patients who are currently taking fluoxetine or who have previously taken it are not eligible for the study.
- Other protocol-defined Inclusion/Exclusion criteria may apply.
Trial locations and contacts
17 sites in 1 country.
17 sites in 1 country
United States17 sites
Long Island Jewish Hospital
Bethpage, New York, 11714
University of North Carolina
Chapel Hill, North Carolina, 27514
University of Illinois
Chicago, Illinois, 60637-1448
Ohio State University
Columbus, Ohio, 43210
Children's Hospital of Michigan
Detroit, Michigan, 48201
University of Florida, Department of Psychiatry
Gainesville, Florida, 32611
Red Oak Psychiatry Associates
Houston, Texas, 77090
Center for Psychiatry and Behavioral Medicine
Las Vegas, Nevada, 89128
Harvard Medical School
Medford, Massachusetts, 02155
AMR-Baber Research Inc.
Naperville, Illinois, 60563
Mount Sinai School of Medicine
New York, New York, 10029
Southwest Autism Research and Resource Centre
Phoenix, Arizona, 85006
Western Psychiatric Institute and Clinic/ Merck Child Outpatient Clinic
Pittsburgh, Pennsylvania, 15203
University of California Davis
Sacramento, California, 95817
Seattle Children's Hosptial University of Washington
Seattle, Washington, 98105-0371
Institute for Behavioral Medicine
Smyrna, Georgia, 30080
CRCNJ
Voorhees Township, New Jersey, 08043
About this study
Official title: Study Of Fluoxetine In Autism: A Randomised, Double-Blind, Placebo-Controlled, Parallel-Group 14-Week Study To Investigate The Effect Of Fluoxetine Orally Dissolving Tablet (ODT) On Repetitive Behaviors In Childhood And Adolescent Autistic Disorder.
The purpose of this study is to assess the effect of fluoxetine orally dissolving tablets (ODT) on the repetitive behaviors core domain in children and adolescents with Autistic Disorder. The study will also investigate the effect of fluoxetine on the improvement of symptoms and the effects on daily living of the patient's family.
- Conditions
- Autistic Disorder
- Being tested
- Fluoxetine, Placebo
- Keywords
- Autism, children, adolescent, Fluoxetine, Autistic Disorder, Repetitive behavior, SSRI, Selective Serotonin Reuptake Inhibitor
- 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
Also called NPL-2008
Once daily oral dispersible tablet 2mg 9mg or 18mg
PlaceboDrug
Oral dispersible tablet placebo
| Study group | Role | What they receive |
|---|---|---|
| Fluoxetine | Experimental | Not described Receives: Drug: Fluoxetine |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
The percentage change from baseline to the endpoint visit for the CYBOCS-PDD score.
Measured: Throughout the study
Secondary outcomes (4)
The time and dose related course of therapeutic effects
Measured: Throughout the study
The inter-relationship between these effects in the context of global clinical changes.
Measured: Throughout the study
The indirect effects on patient caregivers of the dose regime in these subjects compared to placebo during treatment.
Measured: Throughout the study
Safety measures will be physical examination, vital signs, EKG/ECG & clinical laboratory tests.
Measured: 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 posted13 Aug 2007 (estimated)
- Study startAug 2007
- Primary completionJan 2009
- Study completionJan 2009
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 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 158 participants (actual)
Sponsor and investigators
- Lead sponsor
- Neuropharm
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Autism Speaks
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00515320
- Sponsor's protocol ID
- NPL-2008-4-AUTUS-004
- Acronym
- SOFIA
- Status last verified
- Apr 2012
- First submitted
- 10 Aug 2007
- Last updated
- 27 Apr 2012
- 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 37811711Herscu P, Handen BL, Arnold LE, Snape MF, Bregman JD, Ginsberg L, Hendren R, Kolevzon A, Melmed R, Mintz M, Minshew N, Sikich L, Attalla A, King B, Owley T, Childress A, Chugani H, Frazier J, Cartwright C, Murphy T; Autism Speaks Autism Clinical Trials Network. The SOFIA Study: Negative Multi-center Study of Low Dose Fluoxetine on Repetitive Behaviors in Children and Adolescents with Autistic Disorder. J Autism Dev Disord. 2020 Sep;50(9):3233-3244. doi: 10.1007/s10803-019-04120-y.
PubMed 31267292
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study Of Fluoxetine In Autism: A Randomised, Double-Blind, Placebo-Controlled, Parallel-Group 14-Week Study To Investigate The Effect Of Fluoxetine Orally Dissolving Tablet (ODT) On Repetitive Behaviors In Childhood And Adolescent Autistic Disorder.
- ClinicalTrials.gov ID
- NCT00515320
- Acronym / sponsor ID
- SOFIA / NPL-2008-4-AUTUS-004
- Conditions
- Autistic Disorder
- Keywords
- Autism, children, adolescent, Fluoxetine, Autistic Disorder, Repetitive behavior, SSRI, Selective Serotonin Reuptake Inhibitor
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 158 participants (actual)
- Lead sponsor
- NeuropharmIndustry (pharma, biotech, devices)
- Collaborators
- Autism Speaks
- Study start
- Aug 2007
- Primary completion
- Jan 2009 (actual)
- Study completion
- Jan 2009 (actual)
- First posted
- 13 Aug 2007 (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.
The purpose of this study is to assess the effect of fluoxetine orally dissolving tablets (ODT) on the repetitive behaviors core domain in children and adolescents with Autistic Disorder. The study will also investigate the effect of fluoxetine on the improvement of symptoms and the effects on daily living of the patient's family.
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 |
|---|---|---|
| Fluoxetine | Experimental | Drug: Fluoxetine |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 5 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Meets DSM-IV criteria for autistic disorder, .
- CYBOCS-PDD score of at least 10 at screening.
Key exclusion criteria (4 listed)
- Diagnosis of Asperger Syndrome or Pervasive Developmental Disorder Not Otherwise Specified, Rett Syndrome, Childhood Disintegrative Disorder.
- Patients planning to commence cognitive behaviour therapy during the period of the study or those who have begun cognitive behaviour therapy within 8 weeks prior to enrolment.
- Patients who are currently taking fluoxetine or who have previously taken it are not eligible for the study.
- Other protocol-defined Inclusion/Exclusion criteria may apply.
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 |
|---|---|---|
| FluoxetineAlso: NPL-2008Once daily oral dispersible tablet 2mg 9mg or 18mg | Drug | Fluoxetine |
| PlaceboOral dispersible tablet placebo | Drug | Placebo |
Primary outcome
The percentage change from baseline to the endpoint visit for the CYBOCS-PDD score.
Time frame: Throughout the study
4 secondary outcomes
The time and dose related course of therapeutic effects
Time frame: Throughout the study
The inter-relationship between these effects in the context of global clinical changes.
Time frame: Throughout the study
The indirect effects on patient caregivers of the dose regime in these subjects compared to placebo during treatment.
Time frame: Throughout the study
Safety measures will be physical examination, vital signs, EKG/ECG & clinical laboratory tests.
Time frame: 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 27 Apr 2012.
- 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.
- Derived from this study: PubMed 31267292Herscu P, Handen BL, Arnold LE, Snape MF, Bregman JD, Ginsberg L, Hendren R, Kolevzon A, Melmed R, Mintz M, Minshew N, Sikich L, Attalla A, King B, Owley T, Childress A, Chugani H, Frazier J, Cartwright C, Murphy T; Autism Speaks Autism Clinical Trials Network. The SOFIA Study: Negative Multi-center Study of Low Dose Fluoxetine on Repetitive Behaviors in Children and Adolescents with Autistic Disorder. J Autism Dev Disord. 2020 Sep;50(9):3233-3244. doi: 10.1007/s10803-019-04120-y.
- www.autismspeaks.orgLink provided by the sponsor.
- www.neuropharm.co.ukLink provided by the sponsor.
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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.
The record lists no contact. Use the official record to reach the sponsor.
17 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Fluoxetine in people with Autistic Disorder, run by Neuropharm at 17 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?
The sponsor lists 2 inclusion and 4 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 27 Apr 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 17 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. 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 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?
The percentage change from baseline to the endpoint visit for the CYBOCS-PDD score. (time frame: Throughout the study). 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 NCT00515320, 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 27 Apr 2012.