Home
Search
Study Topics
Glossary
|
|
|
|
|
Sponsors and Collaborators: |
Massachusetts General Hospital Stanley Medical Research Institute North Suffolk Mental Health Association |
---|---|
Information provided by: | Massachusetts General Hospital |
ClinicalTrials.gov Identifier: | NCT00383747 |
Patients with schizophrenia have a variety cognitive deficits and nicotine has been shown to normalize some of these deficits. The purpose of this study is to investigate the effects of nicotine on cognition in schizophrenia.We will evaluate the effects of transdermal nicotine compared with placebo for attentional impairments in non-smokers with schizophrenia and controls.
Condition | Intervention | Phase |
---|---|---|
Schizophrenia |
Drug: transdermal nicotine patch |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Crossover Assignment, Efficacy Study |
Official Title: | A Double Blind Placebo Controlled Trial of the Effects of Transdermal Nicotine on Cognitive Function in Non-Smokers With and Without Schizophrenia |
Estimated Enrollment: | 60 |
Study Start Date: | April 2004 |
Estimated Study Completion Date: | June 2006 |
We propose to test the efficacy and safety of transdermal nicotine for attention and working memory in outpatients with stable symptoms of schizophrenia treated with high potency antipsychotic medications that do not smoke cigarettes or use nicotine-containing products. This is a randomized, double-blind, placebo-controlled pilot study to determine whether transdermal nicotine, initiated in a clinic setting and dosed for four hours is safe and effective for improving attention and spatial working memory deficits in patients with schizophrenia. This is an add-on study, subjects will continue with their usual medications and treatments throughout.
Subjects are 30- non-smoking outpatients with stable treated schizophrenia and 30 normal controls who do not have a major mental illness and who are matched for age sex and parental education. Subjects are randomized to one of 2 groups for order of receiving active and placebo patch, using a computer generated random number sequence. Randomization is concealed using opaque envelopes. Assessors and subjects are blind to group allocation.
The primary outcome measure is d’ measure on the CPT-IP following a 4 hour administration of the transdermal nicotine patch. Secondary outcome measures are performance on tasks assessing attention, numeric and visuospatial working memory, psychomotor ability, executive functioning and motivation for reward following nicotine patch administration. Specific Aims
To evaluate the effectiveness of transdermal nicotine compared with placebo for attentional impairment in patients with schizophrenia
Hypothesis 1.1: Subjects will demonstrate greater signal detection as measured by the d’ (hits vs. false alarms) on the Continuous Performance Test Identical Pairs Version (CPT-IP) following 4-hour nicotine administration when compared with placebo administration.
Hypothesis 1.2: Subjects will demonstrate decreased false alarms on the CPT-IP following 4-hour nicotine administration when compared with placebo administration. Hypothesis 1.3: Subjects will demonstrate decreased reaction time on the CPT-IP following 4- hour nicotine administration when compared with placebo administration.
Hypothesis 2.1: Schizophrenia subjects will demonstrate greater improvement in signal detection as measured by the d’ (hits vs. false alarms) on the Continuous Performance test identical pairs version(CPT-IP) following 4-hour nicotine administration when compared with normal controls.
Hypothesis 2.2: Schizophrenia subjects will demonstrate greater reduction in false alarms on the CPT-IP following 4-hour nicotine administration when compared with normal controls. Hypothesis 2.3: Schizophrenia subjects will demonstrate decreased reaction time on the CPT-IP following 4- hour nicotine administration when compared with normal controls. Performance Test Identical Pairs Version
Ages Eligible for Study: | 18 Years to 60 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Patients:
Non Smoking defined by:
Inclusion Criteria:
Control Group:
Exclusion Criteria:
Patients:
Exclusion criteria:
Controls:
United States, Massachusetts | |
Massachusetts General Hospital Schizophrenia Research Program | |
Boston, Massachusetts, United States, 02114 |
Principal Investigator: | A E EVINS, MD MPH | Massachusetts General Hosptal |
Study ID Numbers: | 04T574, CORRC 07-04 |
Study First Received: | September 29, 2006 |
Last Updated: | October 2, 2006 |
ClinicalTrials.gov Identifier: | NCT00383747 History of Changes |
Health Authority: | United States: Federal Government |
cognition nicotine schizophrenia |
Nicotine polacrilex Schizophrenia Neurotransmitter Agents Nicotine Mental Disorders Nicotinic Agonists |
Central Nervous System Stimulants Psychotic Disorders Peripheral Nervous System Agents Cholinergic Agents Schizophrenia and Disorders with Psychotic Features |
Nicotine polacrilex Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Cholinergic Agonists Nicotinic Agonists Physiological Effects of Drugs Central Nervous System Stimulants Cholinergic Agents Pharmacologic Actions |
Schizophrenia Mental Disorders Nicotine Autonomic Agents Therapeutic Uses Ganglionic Stimulants Peripheral Nervous System Agents Central Nervous System Agents Schizophrenia and Disorders with Psychotic Features |