Divalproex Sodium ER in Adult Autism

NCT00211796 | Completed Phase 4

• 1 other identifier: GCO#04-1106
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Autism

Keywords

autism; divalproex sodium ER; aggression; irritability

Outcome Measures

Primary Outcomes (3)

• the Clinical Global Improvement and Severity scales (CGI-I and CGI-S)

• Overt Aggression Scale-Modified (OAS M)

• Affective Lability Scale (ALS).

Secondary Outcomes (8)

• Global Assessment of Functioning Scale (GAF)

• Aggression Questionnaire (AQ)

• the Hamilton Depression (Ham-D) Scale

• Yale Brown Obsessive Compulsion Scale (YBOCS)

• Compulsion sub-scale

Interventions

Divalproex Sodium ER DRUG

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Montefiore Medical Center: lead

Study Sites (1)

Mount Sinai School of Medicine

New York, New York, 10029, United States

Location

MeSH Terms

Conditions

Autistic Disorder; Aggression

Condition Hierarchy (Ancestors)

Autism Spectrum Disorder; Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders; Aberrant Motor Behavior in Dementia; Behavioral Symptoms; Behavior; Social Behavior

Study Officials

• Eric Hollander, MD

  Icahn School of Medicine at Mount Sinai

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 13, 2005
• First Posted: September 21, 2005
• Study Start: April 1, 2005
• Primary Completion: April 1, 2007
• Study Completion: April 1, 2007
• Last Updated: May 31, 2018

Record last verified: 2018-05

Locations

US (1)