Nicotinic Receptors and Schizophrenia

This study is currently recruiting participants.
Verified January 2014 by University of Colorado, Denver
Sponsor:
Collaborator:
Information provided by (Responsible Party):
University of Colorado, Denver
ClinicalTrials.gov Identifier:
NCT01400477
First received: July 14, 2011
Last updated: January 24, 2014
Last verified: January 2014

July 14, 2011
January 24, 2014
July 2011
June 2014   (final data collection date for primary outcome measure)
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. A new algorithm for computing the MATRICS CCB Overall Composite T-Score using only six cognitive domains and omitting the Social Cognition domain will be used to compute the primary outcome.
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.
Complete list of historical versions of study NCT01400477 on ClinicalTrials.gov Archive Site
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
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
Not Provided
Not Provided
 
Nicotinic Receptors and Schizophrenia
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 also smoke cigarettes. 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 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.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Schizophrenia
  • Schizoaffective Disorder
  • 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
  • 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

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
150
June 2014
June 2014   (final data collection date for primary outcome measure)

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.
Both
18 Years to 65 Years
No
Contact: Emma Lyons, BA 303-724-6214 emma.lyons@ucdenver.edu
Contact: Ann Olincy, MD 303-724-6209 ann.olincy@ucdenver.edu
United States
 
NCT01400477
11-0459, 5P50MH086383-02, R01MH061412-05, VA Merit Review grant
Yes
University of Colorado, Denver
University of Colorado, Denver
National Institute of Mental Health (NIMH)
Principal Investigator: Robert Freedman, MD University of Colorado, Denver
University of Colorado, Denver
January 2014

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