Phase 2 Completed N=80 Randomized Triple-blind Treatment

Nicotinic Receptors and Schizophrenia

Schizophrenia · schizoaffective disorder

Source: ClinicalTrials.gov NCT01400477 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

May 2019

Primary outcomePrimary: Neurocognitive Efficacy — 0.6; 2.1 MATRICS Neurocognitive T score — p=0.89

Summary

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.

Outcome Measures

Outcome	Result	p-value
PRIMARY Neurocognitive Efficacy	0.6; 2.1	0.89
SECONDARY Inhibition of Auditory Evoked Potential P50 to Repeated Stimuli	0.57; 0.52	—

Eligibility Criteria

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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01400477). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.