Varenicline for Cognitive Deficits and Cigarette Smoking in Schizophrenia - Efficacy and Predictors
|ClinicalTrials.gov Identifier: NCT00802919|
Recruitment Status : Completed
First Posted : December 5, 2008
Results First Posted : December 2, 2017
Last Update Posted : December 2, 2017
|Condition or disease||Intervention/treatment||Phase|
|Schizophrenia Cigarette Smoking||Drug: Varenicline Drug: Placebo for varenicline||Phase 4|
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 medication and were cigarette smokers. Three sites (2 U.S., 1 Israel) were supported by the Stanley grant. A similar independently supported study was conducted in Beijing, China. We were allowed to access these data and combine them for our analysis of results. Subjects at each site participated in a protocol which was approved by their institutional IRB. All subjects signed informed consent.
The study evaluated multiple measures of cigarette smoking, cognitive functions by MATRICS battery (Measurement and Treatment Research to Improve Cognition in Schizophrenia), and psychiatric symptoms by PANSS (Positive and Negative Symptom Scale), SANS (Schedule For Assessment Of Negative Symptoms), and Calgary Depression scales. Lymphocytes were collected for measurement of epigenetically related mRNA's.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||93 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||Varenicline for Cognitive Deficits and Cigarette Smoking in Schizophrenia - Efficacy and Predictors, Independent Investigator Study|
|Study Start Date :||September 2008|
|Primary Completion Date :||December 2013|
|Study Completion Date :||December 2013|
Varenciline 1-2 mg/day
Varenicline 1-2 mg/day
Other Name: Chantix
Placebo Comparator: Matched Placebo
placebo for varenicline
Drug: Placebo for varenicline
- Cotinine Level [ Time Frame: Baseline, 4 weeks, 8 weeks ]plasma cotinine
- Change From Baseline in Cognitive Performance [ Time Frame: basline and 8 weeks (or end of study iif patient ended participation before the 8-weeks) ]The MATRICS Consensus Cognitive Battery (MCCB)(Measurement and Treatment Research to Improve Cognition in Schizophrenia) was used to measure cognitive performance. Six Domain scores and a Composite score are calculated by the proprietary MCCB Computer Scoring Program (modified beta version) from raw scores on 10 individually administered subtests. The social cognition test was not assessed in this study. The Domain T-scores are percentile-ranked and range from <20 (<0.1 percentile) to >80 (>99.9 percentile). The Composite scores are also percentile-ranked and range from <213 (T<20, <0.1 percentile) to >487 (T>80, >99.9 percentile). Higher scores after baseline represent better outcomes. Here we report difference scores from post-treatment and baseline with positive difference scores representing better outcomes.
- Change From Baseline in Psychiatric Symptoms [ Time Frame: baseline, 4 weeks, 8 weeks ]The Positive and Negative Syndrome Scale (PANSS) was used to measure psychiatric symptoms. Item scores ranged from 1 (Absent) to 6 (Severe) for symptoms on the Positive Scale (total subscale range: 7-42), the Negative Scale (total subscale range: 7-42), and the General Psychopathology Scale (total subscale range:16-96). All three subscales were summed for the PANSS total score (total scale range: 30-180). Scores closer to 30 after baseline represented better outcomes. Here we report difference scores from post-treatment and baseline with negative difference scores representing better outcomes.
- Change From Basellne in Calgary Depression Scale Score [ Time Frame: baseline, 4 weeks, 8 weeks ]The Calgary Depression Scale for Schizophrenia. The scale has 9 items with ratings of 0 to 3 on each item. Total score can vary from 0 to 27. Higher scores indicate more depression. Negative change scores indicate decreasing depression.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00802919
|United States, New York|
|Manhattan Psychatirc Center|
|New York, New York, United States, 10035|
|Nathan Kline Insitute for Psychiatric Research|
|Orangeburg, New York, United States, 10962|
|Peking University Institute of Mental Health|
|Beijing, China, 100191|
|The Division of Psychiatry, Chaim Sheba Medical Center|
|Tel Hashomer, Israel, 52621|
|Principal Investigator:||Robert C. Smith, MD, PhD||Nathan Kline Institute for Psychiatric Research|