Status:
COMPLETED
Varenicline for Cognitive Deficits and Cigarette Smoking in Schizophrenia - Efficacy and Predictors
Lead Sponsor:
Nathan Kline Institute for Psychiatric Research
Conditions:
Schizophrenia
Cigarette Smoking
Eligibility:
All Genders
18-65 years
Phase:
PHASE4
Brief Summary
This is a 8-week double-blind placebo controlled parallel group study of the efficacy of varenicline (Chantix) for smoking cessation in schizophrenic patients, and its effect on cognitive function in ...
Detailed Description
This was a double-blind placebo controlled study of varenicline and matched placebo in patients with a diagnosis of schizophrenia or schizoaffective psychosis who were treated with antipsychotic medic...
Eligibility Criteria
Inclusion
- Diagnosis of Schizophrenia or Schizoaffective Disorder Current Cigarette Smoker or History of Chronic Cigarette smoking Age 18-65 Currently taking antipsychotic medication
Exclusion
- prior history of hospitalization for acute myocardial infarction or stroke, or persistent angina pectoris with current symptoms Patients who have previously tried varenicline and have stopped taking it because of side-effects of severe nausea or vomiting suicide attempt in the last year and or have had prominent or serious suicidal thoughts in the past year Women who are pregnant, nursing, or unable to use reliable contraception significant renal impairment(Creatinine ≥ 1.5) baseline Hamilton Depression Scores is \>20
Key Trial Info
Start Date :
September 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2013
Estimated Enrollment :
93 Patients enrolled
Trial Details
Trial ID
NCT00802919
Start Date
September 1 2008
End Date
December 1 2013
Last Update
December 2 2017
Active Locations (4)
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1
Manhattan Psychatirc Center
New York, New York, United States, 10035
2
Nathan Kline Insitute for Psychiatric Research
Orangeburg, New York, United States, 10962
3
Peking University Institute of Mental Health
Beijing, China, 100191
4
The Division of Psychiatry, Chaim Sheba Medical Center
Tel Litwinsky, Israel, 52621