Nicotinic Receptors and Schizophrenia

Schizophrenia Clinical Trial

Official title:

Nicotinic Receptors and Schizophrenia: Phase II

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01400477
• Other study ID #: 11-0459
• Secondary ID: 5P50MH086383-02R
• Status: Completed
• Phase: Phase 2
• Start date: July 2011
• Est. completion date: June 2015

Study information

• Verified date: April 2019
• Source: University of Colorado, Denver
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 97
• Est. completion date: June 2015
• Est. primary completion date: June 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Psychotic Disorders
• Schizoaffective Disorder
• Schizophrenia

Intervention

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

Other:
• Placebo
Placebo Comparator

Locations

Country	Name	City	State
United States	UColorado Denver	Aurora	Colorado
United States	University of Colorado-Anschutz Medical Campus, Department of Psychiatry	Aurora	Colorado

Sponsors (2)

Lead Sponsor	Collaborator
University of Colorado, Denver	National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

References & Publications (2)

Freedman R, Olincy A, Buchanan RW, Harris JG, Gold JM, Johnson L, Allensworth D, Guzman-Bonilla A, Clement B, Ball MP, Kutnick J, Pender V, Martin LF, Stevens KE, Wagner BD, Zerbe GO, Soti F, Kem WR. Initial phase 2 trial of a nicotinic agonist in schizophrenia. Am J Psychiatry. 2008 Aug;165(8):1040-7. doi: 10.1176/appi.ajp.2008.07071135. Epub 2008 Apr 1. — View Citation

Olincy A, Harris JG, Johnson LL, Pender V, Kongs S, Allensworth D, Ellis J, Zerbe GO, Leonard S, Stevens KE, Stevens JO, Martin L, Adler LE, Soti F, Kem WR, Freedman R. Proof-of-concept trial of an alpha7 nicotinic agonist in schizophrenia. Arch Gen Psychiatry. 2006 Jun;63(6):630-8. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Neurocognitive Efficacy	MATRICS CCB Neurocognitive T-score (Measurement and Treatment Research to Improve Cognition in Schizophrenia Consensus Cognitive Battery Statistically Adjusted-score). Higher scores indicate better neurocognitive functionality.	4 weeks
Secondary	Inhibition of Auditory Evoked Potential P50 to Repeated Stimuli	The P50 evoked response paired of auditory stimuli S1, S2, is measured. The inhibition is expressed as the ratio P50 S2 amplitude divided by P50 S1 amplitude.	4 weeks

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