Effect of a Hypocretin/Orexin Antagonist on Neurocognitive Performance
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01243060|
Recruitment Status : Completed
First Posted : November 18, 2010
Last Update Posted : October 6, 2014
|Condition or disease||Intervention/treatment||Phase|
|Healthy Volunteers||Drug: Almorexant Drug: Zolpidem 10mg Drug: Placebo||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||203 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Effect of a Hypocretin/Orexin Antagonist on Neurocognitive Performance|
|Study Start Date :||May 2011|
|Actual Primary Completion Date :||July 2014|
|Actual Study Completion Date :||July 2014|
Experimental: Almorexant 100mg
Subjects will receive a one-time dose of Almorexant 100mg.
Experimental: Almorexant 200mg
Subjects will receive a one-time dose of Almorexant 200mg.
Active Comparator: Zolpidem
Subjects will receive a one-time dose of Zolpidem 10mg.
Drug: Zolpidem 10mg
Other Name: Ambien
Placebo Comparator: Placebo
Subjects will receive a one-time dose of Placebo.
One-time dose of Placebo
- A comparison between dosing groups on performance on neurocognitive measures [ Time Frame: Within a 7-hour window post dose. ]
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): NCT01243060
|United States, California|
|San Francisco Veterans Affairs Medical Center|
|San Francisco, California, United States, 94121|
|Principal Investigator:||Thomas Neylan, M.D.||Northern California Institute of Research and Education|