Divalproex Sodium ER in Adult Autism

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2007 by Mount Sinai School of Medicine.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Mount Sinai School of Medicine
ClinicalTrials.gov Identifier:
NCT00211796
First received: September 13, 2005
Last updated: April 17, 2007
Last verified: April 2007
  Purpose

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.


Condition Intervention Phase
Autism
Drug: Divalproex Sodium ER
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Divalproex Sodium ER in Adult Autism

Resource links provided by NLM:


Further study details as provided by Mount Sinai School of Medicine:

Primary Outcome Measures:
  • the Clinical Global Improvement and Severity scales (CGI-I and CGI-S)
  • Overt Aggression Scale-Modified (OAS M)
  • Affective Lability Scale (ALS).

Secondary Outcome Measures:
  • Global Assessment of Functioning Scale (GAF)
  • Aggression Questionnaire (AQ)
  • the Hamilton Depression (Ham-D) Scale
  • Yale Brown Obsessive Compulsion Scale (YBOCS)
  • Compulsion sub-scale
  • Aberrant Behavior Checklist (ABC)
  • Barratt Impulsiveness Scale
  • Version11 (BIS-11).

Estimated Enrollment: 10
Study Start Date: April 2005
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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00211796

Contacts
Contact: Eric Hollander, MD 212-241-3623 eric.hollander@mssm.edu

Locations
United States, New York
Mount Sinai School of Medicine Recruiting
New York, New York, United States, 10029
Contact: Eric Hollander, MD    212-241-3623    eric.hollander@mssm.edu   
Sponsors and Collaborators
Mount Sinai School of Medicine
Investigators
Principal Investigator: Eric Hollander, MD Mount Sinai School of Medicine
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00211796     History of Changes
Other Study ID Numbers: GCO#04-1106
Study First Received: September 13, 2005
Last Updated: April 17, 2007
Health Authority: United States: Food and Drug Administration

Keywords provided by Mount Sinai School of Medicine:
autism
divalproex sodium ER
aggression
irritability

Additional relevant MeSH terms:
Autistic Disorder
Child Development Disorders, Pervasive
Mental Disorders Diagnosed in Childhood
Mental Disorders
Valproic Acid
Anticonvulsants
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
GABA Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Antimanic Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs

ClinicalTrials.gov processed this record on September 16, 2014