Nicotinic Receptors and Schizophrenia
| Status: | Completed |
|---|---|
| Conditions: | Schizophrenia, Psychiatric |
| Therapuetic Areas: | Psychiatry / Psychology |
| Healthy: | No |
| Age Range: | 18 - 65 |
| Updated: | 10/14/2017 |
| Start Date: | July 2011 |
| End Date: | June 2015 |
Nicotinic Receptors and Schizophrenia: Phase II
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.
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.
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 they
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 they will receive repeat clinical, cognitive, and
brain imaging testing and all clinical laboratory examinations and a physical examination,
vital signs, and cardiogram.
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 they
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 they will receive repeat clinical, cognitive, and
brain imaging testing and all clinical laboratory examinations and a physical examination,
vital signs, and cardiogram.
Inclusion Criteria:
- Subjects will be selected to be 18 to 65 years old and in good general health.
- We will include people 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) will be excluded.
- 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.
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