Divalproex Sodium ER in Adult Autism (NCT00211796) | Clinical Trial Compass
CompletedPhase 4
Divalproex Sodium ER in Adult Autism
United States10 participantsStarted 2005-04
Plain-language summary
12-week open label treatment trial of divalproex sodium extended release (Depakote ER) in 10 patients with a diagnosis of autism. Our objective is to determine how well these patients can tolerate the prescribed doses and what added benefits can be attributed to divalproex sodium ER.
Who can participate
Age range18 Years – 65 Years
SexALL
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Inclusion criteria
✓. Meet DSM-IV, ADI, or ADOS criteria for autism spectrum disorder.
✓. Age 18-65.
✓. Be seen as outpatients
✓. Demonstrate capacity to provide authorized informed consent or provide consent for participation by an approved surrogate on the autistic individual's behalf
✓. Sexually active females of childbearing potential must use an acceptable method of birth control and have a negative serum pregnancy test prior to entry into the study.
✓. Score at least 4 (moderately ill) on the Clinical Global Impression-Severity Scale for Autistic Disorder (CGI-AD).
✓. Subject meets the following criteria at pre-study diagnostic assessment and baseline assessment: OAS-M 6 (raw scores).
✓. Subjects on a stable dose of their current psychotropic medication for at least 3 months before entering the study, with the understanding that they must remain on a stable dose throughout the trial. If a subject chooses to taper off their current medications, they will be closely monitored by the study psychiatrist and must be medication free for 2 weeks prior to beginning the study. Additionally, if a subject is currently taking a medication with a known drug interaction with Divalproex Sodium, he/she will be tapered off of that medication under the supervision of the study psychiatrist before undergoing treatment.
Exclusion criteria
✕. Subjects who are pregnant or nursing mothers. Sexually active women of childbearing potential who are not using adequate birth control measures.
What they're measuring
1
the Clinical Global Improvement and Severity scales (CGI-I and CGI-S)
✕. Subjects with any of the following past or present mental disorders: schizophrenia, schizoaffective disorder, bipolar disorder, or organic mental disorders.
✕. Subjects who are a serious suicidal risk.
✕. Subjects with clinically significant or unstable medical illness that would contraindicate participation in the study, including hematopoietic or cardiovascular disease, pancreatitis, liver toxicity, and polycystic ovary syndrome.
✕. Subjects reporting history of encephalitis, phenylketonuria, tuberous schelrosis, fragile X syndrome, anoxia during birth, pica, neurofibromatosis, hypomelanosis of Ito, hypothyroidism, Duchenne muscular dystrophy, and maternal rubella.
✕. Patients with history of the following:
✕. Treatment within the previous 30 days with any drug known to a well-defined potential for toxicity to a major organ