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Nicotinic Receptors and Schizophrenia

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: NCT00952393
Recruitment Status : Completed
First Posted : August 6, 2009
Results First Posted : February 5, 2016
Last Update Posted : February 5, 2016
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
The study determines if a new preparation of a drug designed to treat schizophrenia is more slowly released into the body.

Condition or disease Intervention/treatment Phase
Schizophrenia Drug: Pharmacokinetic Phase 1

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 Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Nicotinic Receptors and Schizophrenia
Study Start Date : January 2010
Primary Completion Date : October 2014
Study Completion Date : October 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Schizophrenia
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Pharmacokinetic
This single arm examines the pharmaco-kinetics of the release of 3-2,4 dimethoxy-benzilidene anabaseine in a hypomellose sustained release formulation.
Drug: Pharmacokinetic
Subject receives 150 mg of compound formulated with hypomellose and Pharmcokinetics is determined
Other Name: GTS-21


Outcome Measures

Primary Outcome Measures :
  1. Blood Levels of Drug [ Time Frame: 12 hours ]
    This is the plasma level of the drug as determined by high performance liquid chromatography.


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy volunteers: males and females who are incapable of pregnancy

Exclusion Criteria:

  • Medical illnesses requiring acute treatment
  • History of seizures
  • Substance abuse including nicotine
Contacts and Locations

Information from the National Library of Medicine

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): NCT00952393


Locations
United States, Colorado
VA Eastern Colorado Health Care System, Denver
Denver, Colorado, United States, 80220
Sponsors and Collaborators
VA Office of Research and Development
Investigators
Principal Investigator: Robert Freedman, MD VA Eastern Colorado Health Care System, Denver
More Information

Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT00952393     History of Changes
Other Study ID Numbers: MHBB-005-09S
First Posted: August 6, 2009    Key Record Dates
Results First Posted: February 5, 2016
Last Update Posted: February 5, 2016
Last Verified: January 2016

Keywords provided by VA Office of Research and Development:
receptors nicotinic

Additional relevant MeSH terms:
Schizophrenia
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders