Phase
Condition
Depression
Bipolar Disorder
Depression (Treatment-resistant)
Treatment
N/AClinical Study ID
Ages 18-90 All Genders
Study Summary
Eligibility Criteria
Inclusion
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
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 thecentral 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 usingprescription oral contraceptives (e.g. estrogen-progestin combinations) ,contraceptive implants (e.g. NorplantTM, DepoProveraTM ), or transdermally deliveredcontraceptives (Ortho EvraTM) before entry and throughout the study; and have anegative serum b-HCG pregnancy test at screening. Note: Abstinence and the use of double barrier contraceptive methods are not acceptable inthis study.
Study Design
Connect with a study center
Massachusetts General Hospital
Boston, Massachusetts 02114
United StatesSite Not Available
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