Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 5:05 PM
Ignite Modification Date:
2025-12-24 @ 5:05 PM
NCT ID:
NCT00455650
Eligibility Criteria:
Inclusion Criteria for Patients with Schizophrenia:
* Males or females ages 18-68
* Axis I diagnosis of schizophrenia or schizoaffective disorder
* Smoking or Non-smoking
* Negative salivary screen for drugs of abuse
* Stable psychiatric treatment for 4 weeks
Exclusion Criteria for Patients with Schizophrenia
* Current (within the last 6 months) DSM-IV diagnosis of bipolar disorder, PTSD, organic mental disorder, or anorexia nervosa
* Substance use disorder other than nicotine or caffeine in the past 6 months
* Orthostatic blood pressure changes at 3 minutes of \> 20 mm Hg systolic or 10 mm Hg diastolic
* Blood Pressure: Women under 50 years of age: Supine baseline systolic blood pressure \< 90 mm Hg; Men under 50 years of age: Supine baseline systolic blood pressure \< 100 mm Hg; Women and men over 50 years of age: Supine baseline systolic blood pressure \< 110 mm Hg
* History of angina, MI within the past 2 years, CHF with LVEF \< 40%
* History of syncope or neurocardiogenic syncope
* History of stroke or TIA's
* Glaucoma
* Pyloric Stenosis
* Current pregnancy or lactation
* Renal Insufficiency/Uremia
* Known allergy to mecamylamine
* Inability to give informed consent
* Cognitive impairment secondary to head injury, dementia, general medical condition, or mental retardation
* Current use of antibiotics or sulfa drugs, vasodilators such as alpha blocking agents and nitrates
* Use of investigational medication or device within one month of randomization
* Chronic use of antihypertensive drugs, including diuretics, will be considered on an individual basis
Inclusion Criteria for Healthy Controls:
* Males or females ages 18-68
* Smoking or Non-smoking
* Negative salivary screen for drugs of abuse
Exclusion Criteria for Healthy Controls:
* Current or lifetime Axis I DSM-IV diagnosis or family history of schizophrenia, schizoaffective disorder, or bipolar disorder
* Current (within past 6 months) Axis I DSM-IV diagnosis of major depressive disorder, eating disorder, generalized anxiety disorder or PTSD
* Substance use disorder other than nicotine or caffeine in the past 6 months
* Orthostatic blood pressure changes at 3 minutes of \> 20 mm Hg systolic or 10 mm Hg diastolic
* Blood Pressure: Women under 50 years of age: Supine baseline systolic blood pressure \< 90 mm Hg; Men under 50 years of age: Supine baseline systolic blood pressure \< 100 mm Hg; Women and men over the age of 50: Supine baseline systolic blood pressure \< 110 mm Hg
* History of angina, MI within the past 2 years, CHF with LVEF \< 40%
* History of syncope or neurocardiogenic syncope
* History of stroke or TIA's
* Glaucoma
* Pyloric Stenosis
* Current pregnancy or lactation
* Renal Insufficiency/Uremia
* Known allergy to mecamylamine
* Inability to give informed consent
* Cognitive impairment secondary to head injury, dementia, general medical condition, or mental retardation
* Current use of antibiotics or sulfa drugs, vasodilators such as alpha blocking agents and nitrates
* Use of investigational medication or device within one month of randomization
* Chronic use of antihypertensive drugs, including diuretics, will be considered on an individual basis
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
68 Years
Study:
NCT00455650
Study Brief:
Protocol Section:
NCT00455650