Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Autism Speaks | OTHER |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fluoxetine | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fluoxetine | Drug | Once daily oral dispersible tablet 2mg 9mg or 18mg |
|
| Measure | Description | Time Frame |
|---|---|---|
| The percentage change from baseline to the endpoint visit for the CYBOCS-PDD score. | Throughout the study |
| Measure | Description | Time Frame |
|---|---|---|
| The time and dose related course of therapeutic effects | Throughout the study | |
| The inter-relationship between these effects in the context of global clinical changes. | Throughout the study | |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Other protocol-defined Inclusion/Exclusion criteria may apply.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Southwest Autism Research and Resource Centre | Phoenix | Arizona | 85006 | United States | ||
| University of California Davis |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37811711 | Derived | 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. | |
| 31267292 | Derived | Herscu 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. |
| Label | URL |
|---|---|
| www.autismspeaks.org | View source |
Not provided
| Type | Date | Date Unknown |
|---|---|---|
| Release | Apr 30, 2013 | |
| Reset | Jun 19, 2013 |
Not provided
Not provided
| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Apr 30, 2013 | Jun 19, 2013 |
| ID | Term |
|---|---|
| D001321 | Autistic Disorder |
| ID | Term |
|---|---|
| D000067877 | Autism Spectrum Disorder |
| D002659 | Child Development Disorders, Pervasive |
| D065886 | Neurodevelopmental Disorders |
| D001523 | Mental Disorders |
Not provided
Not provided
| ID | Term |
|---|---|
| D005473 | Fluoxetine |
| ID | Term |
|---|---|
| D011437 | Propylamines |
| D000588 | Amines |
| D009930 | Organic Chemicals |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Placebo | Drug | Oral dispersible tablet placebo |
|
| The indirect effects on patient caregivers of the dose regime in these subjects compared to placebo during treatment. |
| Throughout the study |
| Safety measures will be physical examination, vital signs, EKG/ECG & clinical laboratory tests. | Throughout the study |
| Sacramento |
| California |
| 95817 |
| United States |
| University of Florida, Department of Psychiatry | Gainesville | Florida | 32611 | United States |
| Institute for Behavioral Medicine | Smyrna | Georgia | 30080 | United States |
| University of Illinois | Chicago | Illinois | 60637-1448 | United States |
| AMR-Baber Research Inc. | Naperville | Illinois | 60563 | United States |
| Harvard Medical School | Medford | Massachusetts | 02155 | United States |
| Children's Hospital of Michigan | Detroit | Michigan | 48201 | United States |
| Center for Psychiatry and Behavioral Medicine | Las Vegas | Nevada | 89128 | United States |
| CRCNJ | Voorhees Township | New Jersey | 08043 | United States |
| Long Island Jewish Hospital | Bethpage | New York | 11714 | United States |
| Mount Sinai School of Medicine | New York | New York | 10029 | United States |
| University of North Carolina | Chapel Hill | North Carolina | 27514 | United States |
| Ohio State University | Columbus | Ohio | 43210 | United States |
| Western Psychiatric Institute and Clinic/ Merck Child Outpatient Clinic | Pittsburgh | Pennsylvania | 15203 | United States |
| Red Oak Psychiatry Associates | Houston | Texas | 77090 | United States |
| Seattle Children's Hosptial University of Washington | Seattle | Washington | 98105-0371 | United States |