Nicotinic Receptors and Schizophrenia

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

97 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-07-31

Study Completion Date

2015-06-30

Brief Summary

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The investigators hypothesize that sustained-release DMXB-A-SR (3-2,4 dimethoxybenzylidene anabaseine sustained release) will provide clinical improvement in cognition in patients with schizophrenia who are smokers and who are non-smokers. The study drug may also maintain abstinence from cigarette smoking and improve other symptoms in patients with schizophrenia.

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Detailed Description

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Patients with schizophrenia will be screened then enrolled for one week placebo trial in addition to their existing antipsychotic medication. If pill compliance is greater than 80%, then they will receive baseline clinical, cognitive, and brain imaging and all clinical laboratory examinations and a physical examination, vital signs, and cardiogram. Then patients will receive in a randomized double blind trial either DMXB-A-SR (3-2,4 dimethoxybenzylidene anabaseine sustained release) or placebo comparator in addition to their existing antipsychotic medication. After one month patients will receive repeat clinical, cognitive, and brain imaging testing and all clinical laboratory examinations and a physical examination, vital signs, and cardiogram.

Conditions

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Schizophrenia Schizoaffective Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Random allocation to a treatment and placebo group.

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

The pharmacist places the treatment or placebo into identical coded vials. Only the pharmacist and the statistician have the code to identify of the treatment.

Study Groups

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DMXB-A-SR

Study Drug: 3-2, 4 dimethoxybenzylidene anabaseine sustained release (DMXB-A-SR), 3-2, 4 dimethoxybenzylidene anabaseine sustained release (GTS-21)

Group Type EXPERIMENTAL

DMXB-A-SR

Intervention Type DRUG

Experimental Study Drug: 3-2, 4 dimethoxybenzylidene anabaseine sustained release (DMXB-A-SR)

Arm #2: Placebo Comparator

Inert capsule to resemble active drug.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

Placebo Comparator

Interventions

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DMXB-A-SR

Experimental Study Drug: 3-2, 4 dimethoxybenzylidene anabaseine sustained release (DMXB-A-SR)

Intervention Type DRUG

Placebo

Placebo Comparator

Intervention Type OTHER

Other Intervention Names

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GTS-21

Eligibility Criteria

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Inclusion Criteria

* Subjects will be selected to be 18 to 65 years old and in good general health.
* Subjects who fulfill Diagnostic and Statistical Manual -IV-Text Revision (DSM-IV-TR) criteria for schizophrenia or schizoaffective disorder.
* Smokers will smoke at least 20 cigarettes per day.
* Non-smokers will also be enrolled.
* Subjects will have normal:

* vital signs,
* hematology,
* serum chemistries,
* EKG, and
* urinalysis with a negative drug screen before entry into the study.
* Subjects will be fluent in English.
* Smoking subjects will be interested in stopping smoking in the near future and not interested in nicotine replacement therapy.

Exclusion Criteria

* Subjects with histories of:

* neurological illness,
* liver disease,
* severe hypertension (cut-off blood pressure 160/100) or
* cardiac disease, or
* renal failure (cut-off creatinine above 1.4).
* Subjects who currently meet DSM-IV-TR criteria for substance dependence other than nicotine, cannabis, or alcohol will be excluded.
* Women who are capable of pregnancy and not on acceptable forms of birth control will be excluded.
* Subjects being treated with Clozapine will be excluded.

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No