Nicotinic Receptors and Schizophrenia
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ClinicalTrials.gov Identifier: NCT00952393 |
Recruitment Status
:
Completed
First Posted
: August 6, 2009
Results First Posted
: February 5, 2016
Last Update Posted
: February 5, 2016
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Sponsor:
VA Office of Research and Development
Information provided by (Responsible Party):
VA Office of Research and Development
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Tracking Information | ||||
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First Submitted Date ICMJE | August 3, 2009 | |||
First Posted Date ICMJE | August 6, 2009 | |||
Results First Submitted Date | November 25, 2015 | |||
Results First Posted Date | February 5, 2016 | |||
Last Update Posted Date | February 5, 2016 | |||
Study Start Date ICMJE | January 2010 | |||
Actual Primary Completion Date | October 2014 (Final data collection date for primary outcome measure) | |||
Current Primary Outcome Measures ICMJE |
Blood Levels of Drug [ Time Frame: 12 hours ] This is the plasma level of the drug as determined by high performance liquid chromatography.
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Original Primary Outcome Measures ICMJE |
Blood Levels of Drug [ Time Frame: 12 hours ] | |||
Change History | Complete list of historical versions of study NCT00952393 on ClinicalTrials.gov Archive Site | |||
Current Secondary Outcome Measures ICMJE | Not Provided | |||
Original Secondary Outcome Measures ICMJE | Not Provided | |||
Current Other Outcome Measures ICMJE | Not Provided | |||
Original Other Outcome Measures ICMJE | Not Provided | |||
Descriptive Information | ||||
Brief Title ICMJE | Nicotinic Receptors and Schizophrenia | |||
Official Title ICMJE | Nicotinic Receptors and Schizophrenia | |||
Brief Summary | The study determines if a new preparation of a drug designed to treat schizophrenia is more slowly released into the body. | |||
Detailed Description | 3-2,4 dimethoxybenzylidene will be compounded with a methyallose compound in doses of 150 and 300 mg. The capsules will be administered singly and eventually bid to determine if sustained blood levels comparable to steady state blood levels seen in previous studies can be determined. Safety and EEG effects will be measured. | |||
Study Type ICMJE | Interventional | |||
Study Phase | Phase 1 | |||
Study Design ICMJE | Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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Condition ICMJE | Schizophrenia | |||
Intervention ICMJE | Drug: Pharmacokinetic
Subject receives 150 mg of compound formulated with hypomellose and Pharmcokinetics is determined
Other Name: GTS-21 |
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Study Arms | Pharmacokinetic
This single arm examines the pharmaco-kinetics of the release of 3-2,4 dimethoxy-benzilidene anabaseine in a hypomellose sustained release formulation.
Intervention: Drug: Pharmacokinetic |
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Publications * | Not Provided | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | ||||
Recruitment Status ICMJE | Completed | |||
Actual Enrollment ICMJE |
10 | |||
Original Estimated Enrollment ICMJE |
20 | |||
Actual Study Completion Date | October 2014 | |||
Actual Primary Completion Date | October 2014 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender |
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Ages | 18 Years to 65 Years (Adult) | |||
Accepts Healthy Volunteers | Yes | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | United States | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT00952393 | |||
Other Study ID Numbers ICMJE | MHBB-005-09S | |||
Has Data Monitoring Committee | Yes | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement | Not Provided | |||
Responsible Party | VA Office of Research and Development | |||
Study Sponsor ICMJE | VA Office of Research and Development | |||
Collaborators ICMJE | Not Provided | |||
Investigators ICMJE |
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PRS Account | VA Office of Research and Development | |||
Verification Date | January 2016 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |