Phase 4
Completed N=69
Varenicline Adjunctive Treatment in Schizophrenia
Schizophrenia · schizoaffective disorder · Schizophreniform Disorder
Source: ClinicalTrials.gov NCT00492349 ↗
Enrolled (actual)
69
Serious AEs
0.0%
Results posted
Dec 2017
Primary outcomePrimary: Hamilton Depression Rating Scale (Ham-D) — 22.9; 20.6; 19.4; 18.6 units on a scale
◆ Published Evidence
Highly cited
141citations · ~9 / year
Effects of moderate-dose treatment with varenicline on neurobiological and cognitive biomarkers in smokers and nonsmokers with schizophrenia or schizoaffective disorder.
Summary
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.
Linked Publications (2)
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Effects of moderate-dose treatment with varenicline on neurobiological and cognitive biomarkers in smokers and nonsmokers with schizophrenia or schizoaffective disorder.
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Nicotine receptor partial agonists for smoking cessation.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Hamilton Depression Rating Scale (Ham-D) |
22.9; 20.6; 19.4; 18.6 | — |
| PRIMARY Memory Saccadic Positional Error, Degrees |
1.6; 1.7; 1.7; 1.8 | — |
| PRIMARY Predictive Pursuit Gain |
0.31; 0.34; 0.24; 0.31 | — |
| PRIMARY Maintenance Pursuit Gain |
0.8; 0.8; 0.8; 0.8 | — |
| PRIMARY Digit Symbol Test |
53.9; 53.2; 55.9; 53.8; 54.2; 54.3 | <0.05 sig |
| PRIMARY Conner's Continuous Performance Test (CPT) Detectability Score |
0.87; 0.87; 0.89; 0.97; 0.95; 0.97 | >0.05 |
| PRIMARY Antisaccade Error Rates |
0.61; 0.54; 0.49; 0.54; 0.45; 0.53 | <0.05 sig |
| PRIMARY P50 |
3.2; 3.1; 3.2; 3.0; 3.2; 2.5 | — |
Eligibility Criteria
Inclusion Criteria
- Age 18-60
- DSM-IV Diagnosis of schizophrenia, schizoaffective disorder, or schizophreniform disorder
- Clinically stable with no change in antipsychotic medications and increase of daily dose for 4 weeks prior to enrollment
- Sufficient understanding of the study and risks (ESC score 10 or above)
Exclusion Criteria
- Major medical illness history including, but not limited to, history of heart attack, stroke, TIA (transient ischemic attack)
- History of organic brain disorders that may affect neurophysiological measurements, including seizure disorder, brain tumor, head injury with evidence of significant cognitive deterioration
- DSM-IV diagnosis of substance dependence within 6 months except nicotine and marijuana
- On nicotine replacement therapy (nicotine patch, gum, or nasal spray)
- Uncontrolled blood pressure (persistent systolic above 155 or diastolic above 95)
- EKG of second or third degree atrioventricular (AV) block
- Renal insufficiency with estimated creatinine clearance <40 ml/min
- Women who have positive urine pregnancy tests
- Women who are pregnant, plan to become pregnant, or in breastfeeding
Data sourced from ClinicalTrials.gov (NCT00492349) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.