- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00211796
Divalproex Sodium ER in Adult Autism
May 29, 2018 updated by: Eric Hollander, Montefiore Medical Center
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.
Study Overview
Detailed Description
Based on positive research with divalproex in children/adolescents with autism, we would like to extend this research to autistic adults with high levels of aggression, irritability, affective instability, or agitation.
We aim to have 10 adult autistic patients enrolled in our study of the treatment of aggression/irritability with divalproex sodium ER.
This will be an open treatment for adult patients to determine if the tolerability of divalproex sodium is better with the extended release.
We propose this open label design because previous double-blinded studies of divalproex sodium were only done in children, not adults.
These results will serve as pilot data for a future blinded study for autistic adults with the extended release formulation.
This naturalistic design will allow for prior stable (3 months) use of concomitant medications.
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.
Study Type
Interventional
Enrollment (Anticipated)
10
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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New York
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New York, New York, United States, 10029
- Mount Sinai School of Medicine
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
- Subjects with active or unstable epilepsy.
- 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:
- 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 at least 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 at least 6 months. Subjects with abnormal EEG but no clinical seizures are also eligible.
- Treatment within the previous 30 days with any drug known to a well-defined potential for toxicity to a major organ
- Subjects with clinically significant abnormalities in laboratory tests or physical exam.
- 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).
- 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.
- Subjects who are already being treated with Divalproex Sodium.
- 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.
- Subjects who reside in a remote geographical area who do not have regular access to transportation to the clinical facility.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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the Clinical Global Improvement and Severity scales (CGI-I and CGI-S)
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Overt Aggression Scale-Modified (OAS M)
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Affective Lability Scale (ALS).
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Secondary Outcome Measures
Outcome Measure |
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Barratt Impulsiveness Scale
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Global Assessment of Functioning Scale (GAF)
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Aggression Questionnaire (AQ)
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the Hamilton Depression (Ham-D) Scale
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Yale Brown Obsessive Compulsion Scale (YBOCS)
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Compulsion sub-scale
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Aberrant Behavior Checklist (ABC)
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Version11 (BIS-11).
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
April 1, 2005
Primary Completion (Actual)
April 1, 2007
Study Completion (Actual)
April 1, 2007
Study Registration Dates
First Submitted
September 13, 2005
First Submitted That Met QC Criteria
September 13, 2005
First Posted (Estimate)
September 21, 2005
Study Record Updates
Last Update Posted (Actual)
May 31, 2018
Last Update Submitted That Met QC Criteria
May 29, 2018
Last Verified
May 1, 2018
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Mental Disorders
- Neurodevelopmental Disorders
- Child Development Disorders, Pervasive
- Autism Spectrum Disorder
- Autistic Disorder
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Central Nervous System Depressants
- Enzyme Inhibitors
- Tranquilizing Agents
- Psychotropic Drugs
- GABA Agents
- Anticonvulsants
- Antimanic Agents
- Valproic Acid
Other Study ID Numbers
- GCO#04-1106
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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