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
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
|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|
- Stuttering Severity Instrument [ Time Frame: 10 minutes ] [ Designated as safety issue: No ]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.
- Clinical Global Impression [ Time Frame: 2 minutes ] [ Designated as safety issue: No ]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.
- Barnes Akathisia Scale [ Time Frame: 3 minutes ] [ Designated as safety issue: Yes ]Measures how restless the subject is during the examination.
|Study Start Date:||September 2012|
|Estimated Study Completion Date:||December 2013|
|Estimated Primary Completion Date:||September 2013 (Final data collection date for primary outcome measure)|
Placebo Comparator: Placebo
This is the comparator. Placebo will be matched to color, taste, size, and smell.
This is an atypical antipsychotic that blocks dopamine and increases serotonin. The dosage will be from 2.5 to 10mg daily throughout the study.
This is an atypical antipsychotic that blocks dopamine and increase the serotonin level.
Other Name: Saphris
|Contact: Inee Byun, BSfirstname.lastname@example.org|
|Contact: David Franklin, Psy.Demail@example.com|
|United States, California|
|University of California Irvine Medical Center||Not yet recruiting|
|Orange, California, United States, 92868|
|Contact: Inee Byun, BS 714-456-3489 firstname.lastname@example.org|
|Contact: David Franklin, Psy.D. 714-456-3781 email@example.com|
|Principal Investigator: Gerald Maguire, M.D.|
|Sub-Investigator: David Franklin, Psy.D.|
|Principal Investigator:||Gerald Maguire, M.D.||UCIMC|