Trial record 16 of 198 for:    Open Studies | "Autistic Disorder"

A Study of Pregnenolone in the Treatment of Individuals With Autism

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2013 by Stanford University
Sponsor:
Information provided by (Responsible Party):
Antonio Hardan, Stanford University
ClinicalTrials.gov Identifier:
NCT01881737
First received: November 28, 2011
Last updated: January 13, 2014
Last verified: June 2013
  Purpose

This study will assess the tolerability and effectiveness of pregnenolone in the treatment of behavioral deficits in adults with autism. Pregnenolone is a naturally occurring hormone found in the body which has been shown to help with the function of nerve cells. It is also shown to modulate the activity of certain brain receptors implicated in autism. We hope to examine the tolerability of pregnenolone in adults with autism.


Condition Intervention Phase
Autistic Disorder
Drug: Pregnenolone
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Open-Label Pilot Study of Pregnenolone in the Treatment of Individuals With Autism

Resource links provided by NLM:


Further study details as provided by Stanford University:

Primary Outcome Measures:
  • Change from Baseline in Dosage Record and Treatment Emergent Symptom (DOTES) at 2, 4, 6, 8, 10, 12, and 16 weeks [ Time Frame: Baseline, 2, 4, 6, 8, 10, 12, and 16 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Social Responsiveness Scale [ Time Frame: 12 and 16 weeks ] [ Designated as safety issue: No ]
  • Sensory Profile Questionnaire [ Time Frame: 12 and 16 weeks ] [ Designated as safety issue: No ]
  • Vineland Adaptive Behavior Scale [ Time Frame: 12 and 16 weeks ] [ Designated as safety issue: No ]
  • Repetitive Behavior Scale [ Time Frame: 12 and 16 weeks ] [ Designated as safety issue: No ]
  • Levels of pregnenolone and its related neurosteroids in peripheral blood [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 20
Study Start Date: July 2011
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Pregnenolone
pregnenolone up to 500 mg/d
Drug: Pregnenolone

With Baseline serving as approximately day 1, twice daily intake of orally administered pregnenolone will occur on a schedule consisting of an up-titration followed by a down-titration as described below.

Days 1-14: 100 mg

Week 1 and 2: 200 mg

Week 3 and 4: 350 mg

Week 5 and 6: 400 mg

Week 7 -12: 500 mg

If the participant is unable to tolerate a specific dose then he/she will be maintained at the highest tolerated dose until down titration occurs.


Detailed Description:

This study will assess the tolerability and effectiveness of pregnenolone in the treatment of behavioral deficits in adults with autism. Pregnenolone is a naturally occurring hormone found in the body which has been shown to help with the function of nerve cells. It is also shown to modulate the activity of certain brain receptors implicated in autism.

Pregnenolone has been used safely in research studies involving individuals with schizophrenia. In the proposed trial, we hope to examine the tolerability of pregnenolone in adults with autism. We hope to see improvement in behavioral outcomes as measured by standardized behavioral measures. Further, we will measure concentrations of pregnenolone and related neuroactive compounds in the blood. The use of pregnenolone has been studied in a number of mental disorders but not autism. Thus, we hope the study will identify new avenues of research for the treatment of autism.

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Outpatients 18-45 years of age;
  2. Males and females who are physically healthy;
  3. Diagnosis of autism based on DSM-IV-TR criteria, the Autism Diagnostic Interview-Revised, and expert clinical evaluation;
  4. Total ABC greater then 21;
  5. Care provider who can reliably bring subject to clinic visits, can provide trustworthy ratings, and interacts with subject on a regular basis;
  6. Ability of subject to swallow the compound;
  7. Stable concomitant medications for at least 2 weeks; and
  8. No planned changes in psychosocial interventions during the open-label pregnenolone trial.

Exclusion Criteria:

  1. DSM-IV-TR diagnosis of schizophrenia, schizoaffective disorder, or psychotic disorder NOS;
  2. Prior adequate trial of pregnenolone;
  3. Active medical problems: unstable seizures, significant physical illness (e.g., serious liver or renal pathology);
  4. Pregnancy or sexually active females (as determined by a urinary pregnancy test in the beginning of the study); and
  5. Subjects taking oil or fat based nutritional supplements will be excluded from the study unless they have been off these compounds for at least 4 weeks
  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: NCT01881737

Contacts
Contact: Robin Libove, BS (650) 736-1235 rlibove@stanford.edu

Locations
United States, California
Stanford University School of Medicine Recruiting
Stanford, California, United States, 94305
Contact: Robin Libove, BS    650-736-1235    rlibove@stanford.edu   
Principal Investigator: Antonio Hardan, MD         
Sub-Investigator: Lawrence Fung, MD, PhD         
Sponsors and Collaborators
Stanford University
Investigators
Principal Investigator: Antonio Hardan, MD Stanford University
  More Information

No publications provided

Responsible Party: Antonio Hardan, Associate Professor, Stanford University
ClinicalTrials.gov Identifier: NCT01881737     History of Changes
Other Study ID Numbers: SU-08092011-8246
Study First Received: November 28, 2011
Last Updated: January 13, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Stanford University:
autism

Additional relevant MeSH terms:
Autistic Disorder
Child Development Disorders, Pervasive
Mental Disorders Diagnosed in Childhood
Mental Disorders

ClinicalTrials.gov processed this record on October 02, 2014