| Criteria: |
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Inclusion Criteria:
- 1. Meet DSM-IV, ADI, or ADOS criteria for autism spectrum disorder. 2. Age 18-65. 3.
Be seen as outpatients 4. Demonstrate capacity to provide authorized informed consent
or provide consent for participation by an approved surrogate on the autistic
individual’s behalf 5. 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.
6. Score at least “4” (moderately ill) on the Clinical Global Impression-Severity
Scale for Autistic Disorder (CGI-AD).
7. Subject meets the following criteria at pre-study diagnostic assessment and
baseline assessment: OAS-M 6 (raw scores).
8. 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:
- 1. Subjects who are pregnant or nursing mothers. Sexually active women of
childbearing potential who are not using adequate birth control measures.
2. Subjects with active or unstable epilepsy. 3. Subjects with any of the following
past or present mental disorders: schizophrenia, schizoaffective disorder, bipolar
disorder, or organic mental disorders.
4. Subjects who are a serious suicidal risk. 5. 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.
6. 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.
7. Patients with history of the following:
- gastrointestinal, liver, or kidney, or other known conditions which will
presently interfere presently with the absorption, distribution, metabolism, or
excretion of drugs.
- cerebrovascular disease or brain trauma
- clinically significant unstable endocrine disorder, such as hypo- or
hyperthyroidism
- recent history or presence of any form of malignancy
- Subjects with an unstable history of seizures cannot participate in the study.
However, subjects who have been seizure-free for 6 months on a stable dose of
anticonvulsant medication other than divalproex sodium or related formulations
(e.g., depakene) may participate, along with non-medicated subjects with a
history of seizures who have been seizure-free for 6 months. Subjects with
abnormal EEG but no clinical seizures are also eligible.
8. Treatment within the previous 30 days with any drug known to a well-defined
potential for toxicity to a major organ 9. Subjects with clinically significant
abnormalities in laboratory tests or physical exam.
10. Subjects with a history of hypersensitivity or severe side effects
associated with the use of divalproex sodium, or other an ineffective prior
therapeutic trial of divalproex sodium (serum levels within range of 50-100
ug/ml for 6 weeks).
11. Subjects who are currently taking a medication with a known drug interaction
with Divalproex Sodium (betamipron, chaparral, cholestyramine, clarithromycin,
comfrey, ethosuximide, evening primrose, felbamate, fosphenytoin, germander,
ginkgo, jin bu huan, kava, mefloquine, panipenem, pennyroyal, primidone,
rifampin, rifapentine, and zidovudine) and refuse to taper off of that
medication.
12. Subjects who are already being treated with Divalproex Sodium. 13. Subjects
with any organic or systemic disease or patients who require a therapeutic
intervention, not otherwise specified, which would confound the evaluation of
the safety of the study medication.
14. Subjects who reside in a remote geographical area who do not have regular
access to transportation to the clinical facility. |