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
Status: | Completed |
---|---|
Conditions: | Psychiatric |
Therapuetic Areas: | Psychiatry / Psychology |
Healthy: | No |
Age Range: | 18 - 50 |
Updated: | 5/5/2014 |
Start Date: | September 2012 |
End Date: | December 2013 |
Contact: | Inee Byun, BS |
Email: | ibyun@uci.edu |
Phone: | 714-456-3489 |
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.
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.
Inclusion Criteria:
Subjects can be enrolled in the study only if they meet all of the following criteria:
1. Subjects must satisfy DSM-IV criteria for stuttering.
2. The nature of stuttering must be developmental in origin with the onset prior to ten
years of age.
3. 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 18-50. 6)Subjects will be of only
English speaking.
Exclusion Criteria:
Subjects will be excluded from the study for any of the following reasons:
1. Stuttering related to a known neurologic cause (e.g. head trauma, stroke).
2. Unstable medical or psychiatric illness.
3. Active substance abuse within three months prior to study inclusion.
4. Any illness that would require the concomitant use of a CNS active medication during
the course of the study.
5. Subjects with Parkinson's dementia or other degenerative neurologic illness.
6. Subjects who are pregnant or nursing an infant.
7. 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.
8. Subjects who suffer from seizures, irregular heartbeat or an elevated blood sugar
level (glucose).
We found this trial at
1
site
101 The City Drive South
Orange, California 92868
Orange, California 92868
714-456-7890
University of California, Irvine Medical Center We are UC Irvine Health. We are a devoted...
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