AzTrials
AzTrials

AutismPhase 4NCT00211796

Divalproex Sodium ER in Adult Autism

A Phase 4 study testing Divalproex Sodium ER in people with Autism, run by Montefiore Medical Center at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Autism
What is being tested?
Divalproex Sodium ER
How many people
10 participants
Where
1 siteUnited States
Study dates
Apr 2005to Apr 2007
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
Show all 19Show fewer
  • 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.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Mount Sinai School of Medicine

    New York, New York, 10029

Other trials in United States

About this study

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.

Read the 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.

Conditions
Autism
Being tested
Divalproex Sodium ER
Keywords
autism, divalproex sodium ER, aggression, irritability
Medical subject headings
Autistic Disorder, Aggression

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Divalproex Sodium ERDrug

What is being measured

The primary outcome is the main question the study is designed to answer.

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

  2. Overt Aggression Scale-Modified (OAS M)

  3. Affective Lability Scale (ALS).

Secondary outcomes (8)

  1. Global Assessment of Functioning Scale (GAF)

  2. Aggression Questionnaire (AQ)

  3. the Hamilton Depression (Ham-D) Scale

  4. Yale Brown Obsessive Compulsion Scale (YBOCS)

  5. Compulsion sub-scale

  6. Aberrant Behavior Checklist (ABC)

  7. Barratt Impulsiveness Scale

  8. Version11 (BIS-11).

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Sep 2005 (estimated)
  2. Study startApr 2005
  3. Primary completionApr 2007
  4. Study completionApr 2007

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
10 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00211796
Sponsor's protocol ID
GCO#04-1106
Status last verified
May 2018
First submitted
13 Sep 2005
Last updated
31 May 2018
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Divalproex Sodium ER in people with Autism, run by Montefiore Medical Center at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 31 May 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

the Clinical Global Improvement and Severity scales (CGI-I and CGI-S). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00211796.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 May 2018.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in