A Phase 2 interventional study of DMXB-A-SR and Placebo in Schizophrenia and Schizoaffective Disorder, sponsored by University of Colorado, Denver. Completed at 2 sites in United States. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2019-05-07.
Sponsored by University of Colorado, Denver · Phase 2, Interventional, and Treatment
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.
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.
3,539 studies on the registry are indexed under Schizophrenia; 473 are open to participants now.
This study's enrollment of 97 is above the median of 70 across 2,924 interventional studies indexed under Schizophrenia.
Browse Schizophrenia studies →University of Colorado, Denver is the lead sponsor of 1,538 studies on the registry; 319 are open to participants now.
Of its 146 completed or terminated interventional studies of FDA-regulated products, 92 (63%) have results posted.
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Subjects will have normal:
Exclusion Criteria:
Subjects with histories of:
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
Inert capsule to resemble active drug.
Other: Placebo
Experimental Study Drug: 3-2, 4 dimethoxybenzylidene anabaseine sustained release (DMXB-A-SR)
Also known as: GTS-21
Placebo Comparator
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.
Time frame: 4 weeks
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.
Time frame: 4 weeks
| Milestone | DMXB-A-SR | Arm #2: Placebo Comparator |
|---|---|---|
| Started | 40 | 40 |
| Completed | 38 | 40 |
| Not completed | 2 | 0 |
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.
| MATRICS Neurocognitive T score | DMXB-A-SR | Arm #2: Placebo Comparator |
|---|---|---|
| Neurocognitive Efficacy | 0.6 ± 5.8 | 2.1 ± 8.2 |
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.
| percentage of amplitude | DMXB-A-SR | Arm #2: Placebo Comparator |
|---|---|---|
| Inhibition of Auditory Evoked Potential P50 to Repeated Stimuli | 0.57 ± 0.12 | 0.52 ± 0.14 |
Collected over 4 weeks. Non-serious events are listed at a 2% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| DMXB-A-SR | 0/40 (0%) | 0/40 (0%) | 0/40 (0%) |
| Arm #2: Placebo Comparator | 0/40 (0%) | 0/40 (0%) | 0/40 (0%) |
| Age, Continuous(years) | DMXB-A-SR | Arm #2: Placebo Comparator | Total |
|---|---|---|---|
| Mean | 46.5 ± 12.4 | 43.2 ± 13.6 | 44.8 ± 12.7 |
| Sex: Female, Male(Participants) | DMXB-A-SR | Arm #2: Placebo Comparator | Total |
|---|---|---|---|
| Female | 8 | 12 | 20 |
| Male | 32 | 28 | 60 |
| Ethnicity (NIH/OMB)(Participants) | DMXB-A-SR | Arm #2: Placebo Comparator | Total |
|---|---|---|---|
| Hispanic or Latino | 1 | 3 | 4 |
| Not Hispanic or Latino | 39 | 37 | 76 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | DMXB-A-SR | Arm #2: Placebo Comparator | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 6 | 10 | 16 |
| White | 32 | 30 | 62 |
| More than one race | 2 | 0 | 2 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Region of Enrollment(participants) | DMXB-A-SR | Arm #2: Placebo Comparator | Total |
|---|---|---|---|
| United States | 40 | 40 | 80 |
Plan to share: Yes — Individual patient description can be obtained from Robert.Freedman@ucdenver.edu. It will be available December 1, 2017.
This study is completed, as verified in Apr 2019. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Gts-21
University of Colorado, Denver →