Nicotinic Receptors and Schizophrenia

This study has been completed.

Sponsor:

ClinicalTrials.gov Identifier:

NCT00952393

First Posted: August 6, 2009

Last Update Posted: February 5, 2016

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.

Information provided by (Responsible Party):

VA Office of Research and Development

Tracking Information

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

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 ]

This is the plasma level of the drug as determined by high performance liquid chromatography.

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

Condition ^ICMJE

Schizophrenia

Intervention ^ICMJE

Drug: Pharmacokinetic

Subject receives 150 mg of compound formulated with hypomellose and Pharmcokinetics is determined

Other Name: GTS-21

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

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

October 2014

Primary Completion Date

October 2014 (Final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Sex/Gender

Sexes Eligible for Study:

All

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

Principal Investigator:

Robert Freedman, MD

VA Eastern Colorado Health Care System, Denver

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

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