A Phase 4 interventional study of Varenicline and Placebo in Schizophrenia, Schizoaffective Disorder and Schizophreniform Disorder, sponsored by University of Maryland, Baltimore. Completed at 3 sites in United States. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2022-01-05.
Sponsored by University of Maryland, Baltimore · Phase 4, Interventional, and Treatment
The principal aim of the project is to conduct an off-label adjunctive clinical trial evaluating varenicline as a treatment for core neurobiological and clinical deficits in schizophrenia, in addition to evaluating for smoking cessation in schizophrenia patients.
This is a double-blind, placebo controlled clinical trial in schizophrenia patients. Outcome measures include biomarkers and clinical symptoms and functions, and smoking cessation. Neurobiological and cognitive markers will be measured for short term (2 weeks) and longer-term (8 weeks). Current schizophrenia treatments are mostly ineffective against primary negative symptoms and the cognitive and information processing deficits associated with the disorder. Previous research has identified several neurophysiological deficits in schizophrenia that are enduring, frequently occurring before psychosis, and mark the disease liability. These schizophrenia endophenotypes provide important targets for novel treatment development as they represent the core deficits of the disorder. We hypothesize that sustained nicotinic and dopaminergic modulation by varenicline may ameliorate the core neurobiological deficits seen in schizophrenia patients, which would lead to subsequent clinical improvement. Neurobiological and neurocognitive markers and clinical and functional measures will be obtained to determine 1) short-term effect of varenicline on biomarkers; and 2) longer-term improvement in clinical symptoms, smoking cessation, and functions; and how biomarker changes predict these improvements.
3,471 studies on the registry are indexed under Schizophrenia; 472 are open to participants now.
This study's enrollment of 91 is above the median of 70 across 2,872 interventional studies indexed under Schizophrenia.
Browse Schizophrenia studies →University of Maryland, Baltimore is the lead sponsor of 687 studies on the registry; 130 are open to participants now.
Of its 90 completed or terminated interventional studies of FDA-regulated products, 63 (70%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Varenicline
Drug: Varenicline
Placebo
Drug: Placebo
Varenicline 0.5mg po qd x 7 days then titrated to Varenicline 0.5mg po bid x 7 weeks
Also known as: Chantix
Placebo 0.5mg po qd x 7 days then titrated to Placebo 0.5mg po bid x 7 weeks
Hamilton Depression Rating Scale (Ham-D)
Ham-D Total Score (range 0 to 54, higher score is worse). Definition is fully described in a peer-review journal reported at Arch Gen Psychiatry 2011 Dec;68(12):1195-206.
Time frame: Week 8
Memory Saccadic Positional Error, Degrees
A saccade is a quick eye movement. Spatial working memory was assessed by memory saccade. Participants were asked to focus on a target while a peripheral cue was flashed. Participants were signaled to look in the direction of the peripheral cue when the central target was removed, and the positional error was calculated as the distance between the saccadic and peripheral target positions. Definition is fully described in a peer-review journal reported at Arch Gen Psychiatry 2011 Dec;68(12):1195-206.
Time frame: Week 8
Predictive Pursuit Gain
Pursuit gain is the averaged artifact-free eye velocity divided by target velocity. Participants are asked to track a target with their eyes. Participants may use a predictive mechanism to perform the tracking. The pursuit gain using the predictive mechanism is calculated. Further definition is fully described in a peer-review journal reported at Arch Gen Psychiatry 2011 Dec;68(12):1195-206.
Time frame: Week 8
Maintenance Pursuit Gain
Pursuit gain is the averaged artifact-free eye velocity divided by target velocity. Eye velocity during the regular eye-tracking period (without foveal stabilization) divided by target velocity was used to calculate the maintenance pursuit gain. Further definition is fully described in a peer-review journal reported at Arch Gen Psychiatry 2011 Dec;68(12):1195-206.
Time frame: Week 8
Digit Symbol Test
Digit symbol test score (0 to no definite upper range, higher score is better). Definition is fully described in a peer-review journal reported at Arch Gen Psychiatry 2011 Dec;68(12):1195-206.
Time frame: Week 0, Week 2 and Week 8
Conner's Continuous Performance Test (CPT) Detectability Score
Conner's CPT Detectability Score (no set normal range, higher is generally better). Definition is fully described in a peer-review journal reported at Arch Gen Psychiatry 2011 Dec;68(12):1195-206.
Time frame: Week 0, Week 2 and Week 8
Antisaccade Error Rates
In antisaccade, participants were asked to focus on a central target. When a peripheral cue was presented, participants were asked to look in an equidistant and opposite direction of the peripheral cue. The error rate is calculated as the number of trials in which the participant looked toward the cue, rather than in the opposite direction, divided by the total number of trials. Further definition is fully described in a peer-review journal reported at Arch Gen Psychiatry 2011 Dec;68(12):1195-206.
Time frame: Week 0, Week 2 and Week 8
P50
P50 response is a measure of the amplitude of the brain wave in response to a sound, where the positive going amplitude of the brain wave occurring at about 50 milliseconds after the sound. Further definition is fully described in a peer-review journal reported at Arch Gen Psychiatry 2011 Dec;68(12):1195-206.
Time frame: Week 0, Week 2 and Week 8
| Milestone | Varenicline | Placebo |
|---|---|---|
| Started | 35 | 34 |
| Week 2 | 32 | 33 |
| Week 8 | 32 | 27 |
| Completed | 32 | 27 |
| Not completed | 3 | 7 |
Ham-D Total Score (range 0 to 54, higher score is worse). Definition is fully described in a peer-review journal reported at Arch Gen Psychiatry 2011 Dec;68(12):1195-206.
| units on a scale | Varenicline | Placebo |
|---|---|---|
| Smoker | 22.9 ± 3.2 | 20.6 ± 3.4 |
| Nonsmoker | 19.4 ± 3.2 | 18.6 ± 2.2 |
A saccade is a quick eye movement. Spatial working memory was assessed by memory saccade. Participants were asked to focus on a target while a peripheral cue was flashed. Participants were signaled to look in the direction of the peripheral cue when the central target was removed, and the positional error was calculated as the distance between the saccadic and peripheral target positions. Definition is fully described in a peer-review journal reported at Arch Gen Psychiatry 2011 Dec;68(12):1195-206.
| degrees | Varenicline | Placebo |
|---|---|---|
| Smoker | 1.6 ± 0.2 | 1.7 ± 0.2 |
| Nonsmoker | 1.7 ± 0.1 | 1.8 ± 0.2 |
Pursuit gain is the averaged artifact-free eye velocity divided by target velocity. Participants are asked to track a target with their eyes. Participants may use a predictive mechanism to perform the tracking. The pursuit gain using the predictive mechanism is calculated. Further definition is fully described in a peer-review journal reported at Arch Gen Psychiatry 2011 Dec;68(12):1195-206.
| velocity ratio | Varenicline | Placebo |
|---|---|---|
| Smoker | 0.31 ± 0.03 | 0.34 ± 0.04 |
| Nonsmoker | 0.24 ± 0.04 | 0.31 ± 0.04 |
Pursuit gain is the averaged artifact-free eye velocity divided by target velocity. Eye velocity during the regular eye-tracking period (without foveal stabilization) divided by target velocity was used to calculate the maintenance pursuit gain. Further definition is fully described in a peer-review journal reported at Arch Gen Psychiatry 2011 Dec;68(12):1195-206.
| velocity ratio | Varenicline | Placebo |
|---|---|---|
| Smoker | 0.8 ± 0.1 | 0.8 ± 0.04 |
| Nonsmoker | 0.8 ± 0.1 | 0.8 ± 0.1 |
Digit symbol test score (0 to no definite upper range, higher score is better). Definition is fully described in a peer-review journal reported at Arch Gen Psychiatry 2011 Dec;68(12):1195-206.
| units on a scale | Varenicline | Placebo |
|---|---|---|
| Week 0 | 53.9 ± 19.3 | 53.2 ± 19.1 |
| Week 2 | 55.9 ± 19.0 | 53.8 ± 20.6 |
| Week 8 | 54.2 ± 20.3 | 54.3 ± 21.7 |
Conner's CPT Detectability Score (no set normal range, higher is generally better). Definition is fully described in a peer-review journal reported at Arch Gen Psychiatry 2011 Dec;68(12):1195-206.
| units on a scale | Varenicline | Placebo |
|---|---|---|
| Week 0 | 0.87 ± 0.38 | 0.87 ± 0.50 |
| Week 2 | 0.89 ± 0.42 | 0.97 ± 0.54 |
| Week 8 | 0.95 ± 0.48 | 0.97 ± 0.53 |
In antisaccade, participants were asked to focus on a central target. When a peripheral cue was presented, participants were asked to look in an equidistant and opposite direction of the peripheral cue. The error rate is calculated as the number of trials in which the participant looked toward the cue, rather than in the opposite direction, divided by the total number of trials. Further definition is fully described in a peer-review journal reported at Arch Gen Psychiatry 2011 Dec;68(12):1195-206.
| percentage errors | Varenicline | Placebo |
|---|---|---|
| Week 0 | 0.61 ± 0.27 | 0.54 ± 0.27 |
| Week 2 | 0.49 ± 0.27 | 0.54 ± 0.26 |
| Week 8 | 0.45 ± 0.26 | 0.53 ± 0.28 |
P50 response is a measure of the amplitude of the brain wave in response to a sound, where the positive going amplitude of the brain wave occurring at about 50 milliseconds after the sound. Further definition is fully described in a peer-review journal reported at Arch Gen Psychiatry 2011 Dec;68(12):1195-206.
| microvolts | Varenicline | Placebo |
|---|---|---|
| Week 0 | 3.2 ± 0.73 | 3.1 ± .71 |
| Week 2 | 3.2 ± 0.75 | 3.0 ± .72 |
| Week 8 | 3.2 ± 0.6 | 2.5 ± .77 |
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Varenicline | — | 0/35 (0%) | 0/35 (0%) |
| Placebo | — | 0/34 (0%) | 0/34 (0%) |
| Age, Continuous(years) | Varenicline | Placebo | Total |
|---|---|---|---|
| Smoker | 43.0 ± 2.5 | 41.5 ± 2.5 | 42.2 ± 2.5 |
| Non-Smoker | 45.7 ± 2.6 | 42.1 ± 3.2 | 43.9 ± 2.8 |
| Sex: Female, Male(Participants) | Varenicline | Placebo | Total |
|---|---|---|---|
| Female | 12 | 10 | 22 |
| Male | 23 | 24 | 47 |
| Region of Enrollment(participants) | Varenicline | Placebo | Total |
|---|---|---|---|
| United States | 35 | 34 | 69 |
| BPRS Total(units on a scale) | Varenicline | Placebo | Total |
|---|---|---|---|
| Smoker | 36.2 ± 1.9 | 35.0 ± 2.0 | 35.6 ± 1.9 |
| Non-Smoker | 31.2 ± 2.0 | 34.0 ± 2.5 | 32.6 ± 2.2 |
| Ham-D Total Score(units on a scale) | Varenicline | Placebo | Total |
|---|---|---|---|
| Smoker | 5.0 ± 0.9 | 5.76 ± 1.15 | 5.38 ± 1.0 |
| Nonsmoker | 5.2 ± 0.7 | 6.6 ± 1.0 | 5.8 ± 0.8 |
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University of Maryland, Baltimore