The Effects of Antihistamines on Pre-Pulse Inhibition (PPI)
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|ClinicalTrials.gov Identifier: NCT01537471|
Recruitment Status : Completed
First Posted : February 23, 2012
Last Update Posted : January 16, 2013
|Condition or disease||Intervention/treatment||Phase|
|Healthy||Drug: Placebo Drug: Meclizine||Phase 1|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||117 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||A Pilot Study of the Effects of Meclizine on Pre-Pulse Inhibition|
|Study Start Date :||January 2012|
|Actual Primary Completion Date :||September 2012|
|Actual Study Completion Date :||September 2012|
A counterbalanced design will be used with each male subject receiving placebo and each of the anti-histamine low (12.5 mg) and high (25 mg) doses in a counterbalanced order to keep order of administration from being confounded with dose level. On one of three visits, a subject will receive placebo. The subject, study coordinator, co-investigator and outcomes assessor will remain blinded to what they received until data analysis is completed.
Other Name: Sugar Pill
A counterbalanced design will be used with each male subject receiving placebo and each of the anti-histamine low (12.5 mg) and high (25 mg) doses in a counterbalanced order to keep order of administration from being confounded with dose level. By the time they finish, they will have all received placebo, 12.5mg meclizine and 25mg meclizine. The subject, study coordinator, co-investigator and outcomes assessor will remain blinded to what they received until data analysis is completed.
Meclizine 12.5 mg
Other Name: Antivert, Dramamine II, Bonine, MedivertDrug: Meclizine
Meclizine 25 mg
Other Name: Antivert, Dramamine II, Bonine, Medivert
- Change in PPI [ Time Frame: Screening Day 1, Days 2-4 ]The primary outcome will measure change in subjects' PPI depending on whether they were given meclizine during the study. Prepulse inhibition (PPI) of the startle reflex by a weak pre-pulse will be assessed during each laboratory session. It is measured using electromyographic (EMG; i.e., for assessing eye blink magnitude) responses.
- Sedation [ Time Frame: Day 2, Day 3, & Day 4 ]A Baseline sedation level at the beginning of each visit will be collected. Then study drug (meclizine/placebo) will be given and a sedation level will be collected at 20 minutes and 40 minutes post drug as well as during the PPI experiment pre & post. The Sedation scale will be used (a modified version of the SAM scale).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01537471
|United States, North Carolina|
|Duke University Medical Center|
|Durham, North Carolina, United States, 27705|
|Principal Investigator:||Mark Z Rosenthal, PhD||Duke University|
|Principal Investigator:||Ed Levin, MD||Duke University|