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 @ 10:10 PM
Ignite Modification Date:
2025-12-24 @ 10:10 PM
NCT ID:
NCT00566735
Eligibility Criteria:
Inclusion Criteria:
* Criteria to enter the study include males and females between the ages of 18-90 (females must be post menopausal) and a DSM-IV diagnosis of Major Depressive Disorder, Major Depressive Disorder with psychotic features, Bipolar Disorder, depressed type, or Schizoaffective Disorder, depressed type (19).
Exclusion Criteria:
* DSM-IV diagnoses of dementia and its subtypes
* Substance use disorder (active use within the last 6 months)
* Organic mental disorders; seizure disorder
* Unstable physical disorder or physical disorder judged to significantly affect the central nervous system function
* A heart rate of \<60
* A systolic blood pressure \< 90
* Heart block
* Pre-existing sick-sinus
* Chronic treatment with beta blockers
* Any cardiac arrythmia
* Hypotension
* Coronary artery disease
* Liver and renal function impairment
* Urge incontinence, colitis Crohn's disease, GI motility disorders, asthma and COPD
* Treatment with anti-cholinergic and cholinomimetic medications; and
* Female patients who are pregnant.
* Additionally, women subjects must be postmenopausal, surgically sterile, or using prescription oral contraceptives (e.g. estrogen-progestin combinations) , contraceptive implants (e.g. NorplantTM, DepoProveraTM ), or transdermally delivered contraceptives (Ortho EvraTM) before entry and throughout the study; and have a negative serum b-HCG pregnancy test at screening.
Note: Abstinence and the use of double barrier contraceptive methods are not acceptable in this study.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
90 Years
Study:
NCT00566735
Study Brief:
Protocol Section:
NCT00566735