Nicotinic Receptors and Schizophrenia

Phase 2

Completed

• Conditions: Schizoaffective Disorder; Schizophrenia
• Interventions: Other: Placebo; Drug: DMXB-A-SR

• Registration Number: NCT01400477
• Lead Sponsor: 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.

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.

Study Timeline

• Study Start: 2011-07
• Study First Submitted: 2011-07-14
• Study First Submitted QC: 2011-07-20
• Study First Posted: 2011-07-22
• Primary Completion: 2015-06
• Study Completion: 2015-06
• Results First Submitted: 2017-04-21
• Status Verified: 2019-04
• Results First Submitted QC: 2019-04-15
• Last Update Submitted: 2019-04-15
• Results First Posted: 2019-05-07
• Last Update Posted: 2019-05-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 97

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm #2: Placebo Comparator	Placebo	Inert capsule to resemble active drug.
DMXB-A-SR	DMXB-A-SR	Study Drug: 3-2, 4 dimethoxybenzylidene anabaseine sustained release (DMXB-A-SR), 3-2, 4 dimethoxybenzylidene anabaseine sustained release (GTS-21)

Primary Outcome Measures

Name	Time	Method
Neurocognitive Efficacy	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

Name	Time	Method
Inhibition of Auditory Evoked Potential P50 to Repeated Stimuli	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.

Trial Locations

Locations (2)

UColorado Denver; 🇺🇸 Aurora, Colorado, United States

University of Colorado-Anschutz Medical Campus, Department of Psychiatry; 🇺🇸 Aurora, Colorado, United States