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Nicotinic Receptors and Schizophrenia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01400477
Recruitment Status : Completed
First Posted : July 22, 2011
Results First Posted : May 7, 2019
Last Update Posted : May 7, 2019
Sponsor:
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
University of Colorado, Denver

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 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.

Condition or disease Intervention/treatment Phase
Schizophrenia Schizoaffective Disorder Drug: DMXB-A-SR Other: Placebo Phase 2

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 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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 97 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Random allocation to a treatment and placebo group.
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Masking Description: The pharmacist places the treatment or placebo into identical coded vials. Only the pharmacist and the statistician have the code to identify of the treatment.
Primary Purpose: Treatment
Official Title: Nicotinic Receptors and Schizophrenia: Phase II
Study Start Date : July 2011
Actual Primary Completion Date : June 2015
Actual Study Completion Date : June 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Schizophrenia

Arm Intervention/treatment
Experimental: DMXB-A-SR
Study Drug: 3-2, 4 dimethoxybenzylidene anabaseine sustained release (DMXB-A-SR), 3-2, 4 dimethoxybenzylidene anabaseine sustained release (GTS-21)
Drug: DMXB-A-SR
Experimental Study Drug: 3-2, 4 dimethoxybenzylidene anabaseine sustained release (DMXB-A-SR)
Other Name: GTS-21

Placebo Comparator: Arm #2: Placebo Comparator
Inert capsule to resemble active drug.
Other: Placebo
Placebo Comparator




Primary Outcome Measures :
  1. Neurocognitive Efficacy [ Time Frame: 4 weeks ]
    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.


Secondary Outcome Measures :
  1. Inhibition of Auditory Evoked Potential P50 to Repeated Stimuli [ Time Frame: 4 weeks ]
    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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01400477


Locations
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United States, Colorado
UColorado Denver
Aurora, Colorado, United States, 80045
University of Colorado-Anschutz Medical Campus, Department of Psychiatry
Aurora, Colorado, United States, 80045
Sponsors and Collaborators
University of Colorado, Denver
National Institute of Mental Health (NIMH)
Investigators
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Principal Investigator: Robert Freedman, MD University of Colorado, Denver
Additional Information:
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: University of Colorado, Denver
ClinicalTrials.gov Identifier: NCT01400477    
Other Study ID Numbers: 11-0459
5P50MH086383-02 ( U.S. NIH Grant/Contract )
R01MH061412-05 ( U.S. NIH Grant/Contract )
VA Merit Review grant ( Other Grant/Funding Number: VA Merit Review grant )
First Posted: July 22, 2011    Key Record Dates
Results First Posted: May 7, 2019
Last Update Posted: May 7, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Individual patient description can be obtained from Robert.Freedman@ucdenver.edu. It will be available December 1, 2017.
Keywords provided by University of Colorado, Denver:
Drug Trial
Smoking
Smoking Cessation
Cognition
Mental Focus
Additional relevant MeSH terms:
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Schizophrenia
Psychotic Disorders
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders