Nicotinic Receptors and Schizophrenia

This study is currently recruiting participants.

Verified September 2011 by University of Colorado, Denver

Sponsor:

Collaborator:

National Institute of Mental Health (NIMH)

Information provided by (Responsible Party):

University of Colorado, Denver

ClinicalTrials.gov Identifier:

NCT01400477

First received: July 14, 2011

Last updated: January 31, 2013

Last verified: September 2011

History of Changes

Tracking Information

First Received Date ^ICMJE

July 14, 2011

Last Updated Date

January 31, 2013

Start Date ^ICMJE

July 2011

Estimated Primary Completion Date

June 2014 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Efficacy: Clinical, MATRICS CCB T-score and SANS and BPRS Ratings [ Time Frame: 4 weeks ] [ Designated as safety issue: Yes ]

MATRICS CCB T-score (Measurement and Treatment Research to Improve Cognition in Schizophrenia Consensus Cognitive Battery Statistically Adjusted-score) and SANS (Scale for Assessment of Negative Symptoms) and BPRS (Brief Psychiatric Rating Scale) rating; data for primary outcome measures are collected at "baseline" study visit and last study visit, 4 weeks post-"baseline" visit. The primary analysis compares values at 4 weeks, covaried for baseline measurements.

Original Primary Outcome Measures ^ICMJE

Efficacy: Clinical, MATRICS CCB T-score and SANS and BPRS Ratings [ Time Frame: 4 weeks ] [ Designated as safety issue: Yes ]

MATRICS CCB T-score and SANS and BPRS rating; data for primary outcome measures are collected at "baseline" study visit and last study visit, 4 weeks post-"baseline" visit. The primary analysis compares values at 4 weeks, covaried for baseline measurements.

Change History

Complete list of historical versions of study NCT01400477 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Neurobiological, as measured by fMRI SPEM BOLD signal strength [ Time Frame: 4 weeks ] [ Designated as safety issue: Yes ]

Neurobiological, as measured by fMRI SPEM BOLD (Functional Magnetic Resonance Imaging Smooth Pursuit Eye Movement Blood Oxygenation Level Dependent Signal ) signal strength at 4 weeks, experimental drug compared to placebo, covaried for baseline measurements at initiation of trial

Original Secondary Outcome Measures ^ICMJE

Neurobiological, as measured by fMRI SPEM BOLD signal strength [ Time Frame: 4 weeks ] [ Designated as safety issue: Yes ]

Neurobiological, as measured by fMRI SPEM BOLD signal strength at 4 weeks, experimental drug compared to placebo, covaried for baseline measurements at initiation of trial

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Nicotinic Receptors and Schizophrenia

Official Title ^ICMJE

Nicotinic Receptors and Schizophrenia: Phase II

Brief 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 also smoke cigarettes. The study drug may also maintain abstinence from cigarette smoking and improve other symptoms in patients with schizophrenia.

Detailed 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 they will receive in a randomized double blind trial either DMXBA-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.

Study Type ^ICMJE

Interventional

Study Phase

Phase 2

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment

Condition ^ICMJE

Schizophrenia
Schizoaffective Disorder

Intervention ^ICMJE

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

Other Name: GTS-21
Other: Placebo
Placebo Comparator

Study Arm (s)

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

Intervention: Drug: DMXB-A-SR
Placebo Comparator: Arm #2: Placebo Comparator
Inert capsule to resemble active drug.

Intervention: Other: Placebo

Publications *

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

150

Estimated Completion Date

June 2014

Estimated Primary Completion Date

June 2014 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Subjects will be selected to be 18 to 65 years old and in good general health.
We will include people who fulfill DSM-IV-TR criteria for schizophrenia or schizoaffective disorder.
They will smoke at least 20 cigarettes per day. 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.
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.

Gender

Both

Ages

18 Years to 65 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Emma Lyons, BA	303-724-6214	emma.lyons@ucdenver.edu
Contact: Ann Olincy, MD	303-724-6209	ann.olincy@ucdenver.edu

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT01400477

Other Study ID Numbers ^ICMJE

11-0459, 5P50MH086383-02, R01MH061412-05, VA Merit Review grant

Has Data Monitoring Committee

Yes

Responsible Party

University of Colorado, Denver

Study Sponsor ^ICMJE

University of Colorado, Denver

Collaborators ^ICMJE

National Institute of Mental Health (NIMH)

Investigators ^ICMJE

Principal Investigator:

Robert Freedman, MD

University of Colorado, Denver

Information Provided By

University of Colorado, Denver

Verification Date

September 2011

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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