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| ID | Type | Description | Link |
|---|---|---|---|
| U54MH066398 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Mental Health (NIMH) | NIH |
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This study will determine the efficacy and safety of citalopram compared to placebo in the treatment of children with autism.
For children with autism spectrum disorders (ASD, also known as Pervasive Developmental Disorders - PDDs), repetitive behaviors are common and frequently interfere with functioning in the home as well as in social and educational settings. These behaviors may involve repetitive movements, rigid routines, repetitive play, and even repetitive speech. These behaviors may be associated with high levels of anxiety, severe tantrums. Self-injury can occur when these behaviors and routines are interrupted.
Participants will be randomly assigned to receive citalopram or placebo (administered as liquid), and carefully followed every two weeks. At the end of 12 weeks, children who have responded to treatment will be given the opportunity to continue in the study, with monthly visits, for an additional 24 weeks. Children who received placebo and did not respond to treatment at 12 weeks will be given the opportunity to receive a carefully monitored 12 week course of citalopram.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| citalopram hydrobromide | Experimental | citalopram hydrobromide, up to 20 mg daily |
|
| placebo | Placebo Comparator | placebo, up to equivalent of 20 mg of active comparator daily |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| citalopram hydrobromide | Drug | 10mg/5ml solution |
|
| Measure | Description | Time Frame |
|---|---|---|
| Clinical Global Improvement | Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Safety Monitoring Uniform Research Form (SMURF) | post-baseline through week 12 | |
| Children's Yale-Brown Obsessive-Compulsive Scale (CYBOCS) | Week 12 | |
| Repetitive Behavior Scale-Revised (RBS-R) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bryan King, MD | University of Washington | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UCLA Neuropsychiatric Institute | Los Angeles | California | 90024 | United States | ||
| Yale University |
| 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. | |
| 24061784 | Derived | King BH, Dukes K, Donnelly CL, Sikich L, McCracken JT, Scahill L, Hollander E, Bregman JD, Anagnostou E, Robinson F, Sullivan L, Hirtz D. Baseline factors predicting placebo response to treatment in children and adolescents with autism spectrum disorders: a multisite randomized clinical trial. JAMA Pediatr. 2013 Nov;167(11):1045-52. doi: 10.1001/jamapediatrics.2013.2698. |
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| ID | Term |
|---|---|
| D001321 | Autistic Disorder |
| D020817 | Asperger Syndrome |
| D002659 | Child Development Disorders, Pervasive |
| D002562 | Ceremonial Behavior |
| D003192 | Compulsive Behavior |
| D019956 | Stereotypic Movement Disorder |
| ID | Term |
|---|---|
| D000067877 | Autism Spectrum Disorder |
| D065886 | Neurodevelopmental Disorders |
| D001523 | Mental Disorders |
| D012919 | Social Behavior |
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| ID | Term |
|---|---|
| D015283 | Citalopram |
| ID | Term |
|---|---|
| D011437 | Propylamines |
| D000588 | Amines |
| D009930 | Organic Chemicals |
| D009570 | Nitriles |
| D001572 |
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| placebo | Other | up to equivalent of 20 mg of active comparator daily |
|
| Week 12 |
| Parent Chief Complaint | Weeks 6 and 12 |
| Aberrant Behavior Checklist | Week 12 |
| Child and Adolescent Symptom Inventory: Anxiety and Depression scales | Week 12 |
| Behavioral Activation | post-baseline through Week 12 |
| Caregiver Strain Questionnaire | Week 12 |
| Vineland | Week 12 |
| New Haven |
| Connecticut |
| 06510 |
| United States |
| Dartmouth-Hitchcock Medical Center | Lebanon | New Hampshire | 03756 | United States |
| North Shore - Long Island Jewish Hospital | Great Neck | New York | 11021 | United States |
| Mount Sinai School of Medicine | New York | New York | 10029 | United States |
| University of North Carolina Chapel Hill | Chapel Hill | North Carolina | 25714 | United States |
| 19487623 | Derived | King BH, Hollander E, Sikich L, McCracken JT, Scahill L, Bregman JD, Donnelly CL, Anagnostou E, Dukes K, Sullivan L, Hirtz D, Wagner A, Ritz L; STAART Psychopharmacology Network. Lack of efficacy of citalopram in children with autism spectrum disorders and high levels of repetitive behavior: citalopram ineffective in children with autism. Arch Gen Psychiatry. 2009 Jun;66(6):583-90. doi: 10.1001/archgenpsychiatry.2009.30. |
| D001519 | Behavior |
| D007175 | Impulsive Behavior |
| Benzofurans |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |