A Randomized, Placebo-Controlled Study to Evaluate the Efficacy and Tolerability of Asenapine With Flexible Dosing From 5mg to 20mg in Adults With Developmental Stuttering

Study Overview
=================
Brief Summary
-----------------
The purpose of this research study is to find out the potential benefits and safety of asenapine (Saphris®) in adults who suffer from the developmental form of stuttering. It is hypothesized that individuals who are randomly assigned to asenapine will have an improvement in speech as compared to a placebo.

Official Title
-----------------
A Randomized, Placebo-Controlled Study to Evaluate the Efficacy and Tolerability of Asenapine With Flexible Dosing From 5mg to 20mg in Adults With Developmental Stuttering

Conditions
-----------------
Stuttering

Intervention / Treatment
-----------------
* Drug: Asenapine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects can be enrolled in the study only if they meet all of the following criteria: Subjects must satisfy DSM-IV criteria for stuttering. The nature of stuttering must be developmental in origin with the onset prior to ten years of age. Subjects must have a score of moderate or higher on the SSI-IV. 4) Women of child-bearing potential are eligible to participate as long as they are practicing a medically accepted form of contraception (i.e. condom with spermicide or diaphragm, oral or depot contraception, or an intrauterine device). 5)Subjects will be male or female from the ages of 18-70. 6)Subjects will be of only English speaking. Exclusion Criteria: Subjects will be excluded from the study for any of the following reasons: Stuttering related to a known neurologic cause (e.g. head trauma, stroke). Unstable medical or psychiatric illness. Active substance abuse within three months prior to study inclusion. Any illness that would require the concomitant use of a CNS active medication during the course of the study. Subjects with Parkinson's dementia or other degenerative neurologic illness. Subjects who are pregnant or nursing an infant. No minors (under the age of 18) will not be enrolled in this study as the research with this compound in children and adolescents has not been fully performed. Subjects who suffer from seizures, irregular heartbeat or an elevated blood sugar level (glucose).

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br>This is the comparator. Placebo will be matched to color, taste, size, and smell. | |
| Experimental: Asenapine<br>This is an atypical antipsychotic that blocks dopamine and increases serotonin. The dosage will be from 2.5 to 10mg daily throughout the study. | Drug: Asenapine<br>* This is an atypical antipsychotic that blocks dopamine and increase the serotonin level.<br>* Other names: Saphris;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Stuttering Severity Instrument | This is an objective measure of stuttering in which it captures verbal samples of five minutes speaking during a conversation and 5 minutes of reading a passage. | 10 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical Global Impression | This is an evaluation of the patient by the investigator as to whether or not the subjects has improved, remained the same, or worsened while in the study. | 2 minutes | 
| Barnes Akathisia Scale | Measures how restless the subject is during the examination. | 3 minutes | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Stuttering