Clinical Evaluation of Bupropion SR (323U66)in Patients With Depression - Investigation in Elderly Patients With Depression
Clinical Evaluation of Bupropion SR (323U66)in Patients With Depression - Investigation in Elderly Patients With Depression
This is a study to obtain clinical experience of 323U66 SR for elderly patients with depression in repeat-dose of 323U66 SR up to 300mg/day, and to conduct exploratory investigation on safety, efficacy and pharmacokinetics profile in elderly patients with depression.
Inclusion criteria:
Target disease: Patients diagnosed as having the following primary disease and current major depressive episode for at least 8 weeks on the basis of DSM-IV-TR criteria.
HAM-D (17 items) total score >/=18.
Age: >/=65 years old (at the time of informed consent)
Gender: Male or female.
Inpatient or outpatient status: Either
Informed consent: The subject himself/herself must give written informed consent.
Exclusion criteria:
Patients with predisposition to seizure (who currently have or have a past history of seizure, febrile convulsive seizure in infancy, cerebral tumour, cerebrovascular disorder or head injury, who have a family history of idiopathic seizure, patients with diabetes who have been treated with oral hypoglycaemics or insulin, or who use drugs lowering the threshold of seizure)
Patients who currently have or have a past history of the following disorders:
Patients with a history of manic episode
Patients with a past or current DSM- IV-TR diagnosis of schizophrenia or other psychotic disorder
Patients with a current DSM-IV-TR Axis II diagnosis (e.g., antisocial or borderline personality disorder)
Patients starting psychotherapy (except for supportive psychotherapy not aimed at therapeutic efficacy and unlikely to affect efficacy evaluation) and standardized cognitive behaviour therapy within 12 weeks prior to the start of the treatment phase
Patients with a diagnosis of substance abuse (alcohol or drug) by the DSM-IV-TR criteria or with a diagnosis of substance dependence within 1 year prior to the start of the treatment phase
Patients who have received electroconvulsive therapy within 24 weeks prior to the start of the treatment phase
Patients who have taken MAO inhibitors (selegiline hydrochloride) within 2 weeks prior to the start of the treatment phase
Patients who have taken another investigational drug within 12 weeks prior to the start of the pre-treatment phase
Patients who have attempted suicide within 24 weeks prior to the start of the treatment phase, or patients for whom the score of the suicide-related item of HAM-D is >/=3, or patients in whom the risk of suicide is judged to be high by the investigator (sub-investigator).
Patients in whom the risk of homicide is judged to be high by the investigator (sub-investigator).
Patients with a history of hypersensitivity to 323U66
Patients with serious cerebral disease
Patients who have ECG or clinical evidence of any cardiac condition that the investigator (sub-investigator) assesses the subject is predisposed to ischemia or arrhythmia
Patients with serious physical symptoms (i.e. cardiac/hepatic/renal disorder, hematopoietic disorder).
The index of seriousness is Grade 3 of "Criteria for classification of seriousness of adverse drug reactions to pharmaceutical products, etc." (PAB/PSD No.80 in 1992).