Varenicline for Cognitive Deficits and Cigarette Smoking in Schizophrenia - Efficacy and Predictors
Varenicline for Cognitive Deficits and Cigarette Smoking in Schizophrenia - Efficacy and Predictors, Independent Investigator Study
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
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.
Type d'étude
Inscription (Réel)
Phase
- Phase 4
Contacts et emplacements
Lieux d'étude
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Beijing, Chine, 100191
- Peking University Institute of Mental Health
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Tel Hashomer, Israël, 52621
- The Division of Psychiatry, Chaim Sheba Medical Center
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New York
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New York, New York, États-Unis, 10035
- Manhattan Psychatirc Center
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Orangeburg, New York, États-Unis, 10962
- Nathan Kline Insitute for Psychiatric Research
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
Inclusion Criteria:
Diagnosis of Schizophrenia or Schizoaffective Disorder Current Cigarette Smoker or History of Chronic Cigarette smoking Age 18-65 Currently taking antipsychotic medication
Exclusion Criteria:
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
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Double
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
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Expérimental: Varenicline
Varenciline 1-2 mg/day
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Varenicline 1-2 mg/day
Autres noms:
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Comparateur placebo: Matched Placebo
placebo for varenicline
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Placebo
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
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Cotinine Level
Délai: Baseline, 4 weeks, 8 weeks
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plasma cotinine
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Baseline, 4 weeks, 8 weeks
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Change From Baseline in Cognitive Performance
Délai: basline and 8 weeks (or end of study iif patient ended participation before the 8-weeks)
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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.
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basline and 8 weeks (or end of study iif patient ended participation before the 8-weeks)
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
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Change From Baseline in Psychiatric Symptoms
Délai: baseline, 4 weeks, 8 weeks
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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.
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baseline, 4 weeks, 8 weeks
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Change From Basellne in Calgary Depression Scale Score
Délai: baseline, 4 weeks, 8 weeks
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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.
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baseline, 4 weeks, 8 weeks
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Collaborateurs et enquêteurs
Les enquêteurs
- Chercheur principal: Robert C. Smith, MD, PhD, Nathan Kline Institute for Psychiatric Research
Publications et liens utiles
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
- Les troubles mentaux
- Troubles neurocognitifs
- Spectre de la schizophrénie et autres troubles psychotiques
- La schizophrénie
- Dysfonctionnement cognitif
- Troubles cognitifs
- Effets physiologiques des médicaments
- Agents neurotransmetteurs
- Mécanismes moléculaires de l'action pharmacologique
- Agents cholinergiques
- Agonistes nicotiniques
- Agonistes cholinergiques
- Varénicline
Autres numéros d'identification d'étude
- 081/C02
- FDA IND 102,411
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