Nicotinic Receptors and Schizophrenia
This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT00952393
First received: August 3, 2009
Last updated: December 4, 2014
Last verified: December 2014
| Tracking Information | |||||
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| First Received Date ICMJE | August 3, 2009 | ||||
| Last Updated Date | December 4, 2014 | ||||
| Start Date ICMJE | January 2010 | ||||
| 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 ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| 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. |
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| 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. |
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| Study Type ICMJE | Interventional | ||||
| Study Phase | Phase 1 | ||||
| Study Design ICMJE | Allocation: Non-Randomized Endpoint Classification: Pharmacokinetics/Dynamics Study Intervention Model: Single Group Assignment Masking: Single Blind (Subject) Primary Purpose: Treatment |
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| Condition ICMJE | Schizophrenia | ||||
| Intervention ICMJE | Drug: 3-2,4 dimethoxbenzylidene anabaseine
nicotinic agonist |
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| Study Arm (s) | Arm 1
Intervention: Drug: 3-2,4 dimethoxbenzylidene anabaseine |
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| Publications * | Not Provided | ||||
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* 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 | ||||
| Enrollment ICMJE | 10 | ||||
| Completion Date | October 2014 | ||||
| Primary Completion Date | October 2014 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years to 65 Years | ||||
| 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 | ||||
| Responsible Party | Department of Veterans Affairs | ||||
| Study Sponsor ICMJE | Department of Veterans Affairs | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | Department of Veterans Affairs | ||||
| Verification Date | December 2014 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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