Placebo-Controlled Pilot Trial of Mecamylamine for Treatment of Autism Spectrum Disorders

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-07-31

Study Completion Date

2012-11-30

Brief Summary

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The purpose of this study is to examine the safety and efficacy of mecamylamine for the core symptoms of autism.

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Detailed Description

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This is a placebo-controlled pilot clinical trial of a nicotinic agent based on evidence that a disturbance occurs in nicotinic cholinergic transmission in the brain of autistic children. This pharmacotherapeutic trial will be conducted as a direct result of findings of a nicotinic receptor abnormality in autopsied brain tissue from individuals who suffered from autism. A pharmacological agent, mecamylamine, with specificity for the nicotinic receptors implicated in autism, will be tested in children with autism spectrum disorder. Twenty children who meet inclusion/exclusion criteria will be randomized in a 2:3 ratio to 14 weeks of either matched placebo (n=8) or mecamylamine (n=12). Children randomized to placebo who do not respond will be given the opportunity to enroll in a ten week open label extension.

The trial has been completed and published in J. of Child \& Adolescent Psychopharmacology.

Conditions

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Autistic Disorder Pervasive Developmental Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Active Mecamylamine

There will be 12 children in this arm. These children will receive the active medication (mecamylamine).

Group Type EXPERIMENTAL

mecamylamine

Intervention Type DRUG

The dosage is titrated at 6 weeks of .5mg, 2 weeks of 2.5 mg, and 6 weeks of 5.0 mg. One pill is taken once daily.

Placebo

There will be 8 children in this arm. These children will receive placebo instead of the active medication.

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DRUG

One pill is taken once daily.

Interventions

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mecamylamine

The dosage is titrated at 6 weeks of .5mg, 2 weeks of 2.5 mg, and 6 weeks of 5.0 mg. One pill is taken once daily.

Intervention Type DRUG

placebo

One pill is taken once daily.

Intervention Type DRUG

Other Intervention Names

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Inversine

Eligibility Criteria

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Inclusion Criteria

* Autistic Disorder or Pervasive Developmental Disorder-Not Otherwise Specified
* Age 4-12
* General good health
* IQ of \>=36 or mental age of \>=18 months
* Parent/caregiver willingness to accompany child to clinic and monitor for side effects

Exclusion Criteria

* Unstable Seizure Disorder
* Psychoactive medication in the process of adjustment
* Antipsychotic medication in previous 3 months before baseline
* Systemic corticoids (inhalers allowed)
* Planned beginning of major behavioral intervention in 3 months of study or the 2 months prior to the study.

Minimum Eligible Age

4 Years

Maximum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No