Nicotinic Receptors and Schizophrenia

NCT ID: NCT00952393

Last Updated: 2016-02-05

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-01-31

Study Completion Date

2014-10-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Schizophrenia

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Pharmacokinetic

This single arm examines the pharmaco-kinetics of the release of 3-2,4 dimethoxy-benzilidene anabaseine in a hypomellose sustained release formulation.

Group Type OTHER

Pharmacokinetic

Intervention Type DRUG

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

Interventions

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Pharmacokinetic

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

Intervention Type DRUG

Other Intervention Names

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GTS-21

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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VA Office of Research and Development

FED

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Robert Freedman, MD

Role: PRINCIPAL_INVESTIGATOR

VA Eastern Colorado Health Care System, Denver

Locations

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VA Eastern Colorado Health Care System, Denver

Denver, Colorado, United States

Site Status

Countries

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United States

Other Identifiers

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MHBB-005-09S

Identifier Type: -

Identifier Source: org_study_id

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