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OpenTrials
Completed

NCT Number: NCT00952393

Nicotinic Receptors and Schizophrenia

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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Key information

Conditions

Schizophrenia Mental Disorders Schizophrenia Spectrum and Other Psychotic Disorders

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

VA Eastern Colorado Health Care System, Denver

Denver, Colorado, 80220, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Pharmacokinetic

Drug

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

Other names: GTS-21

Primary outcomes

  1. Blood Levels of Drug

    Time frame: 12 hours

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

Sponsors and collaborators

Lead sponsor

VA Office of Research and Development

Fed

Registry information

Important dates

Study start
2010
Primary completion
2014
Study completion
2014
First posted
Aug 6, 2009
Registry last updated
Feb 5, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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