Clinical trial NCT00330616: Study Of Bupropion SR (323U66) In Patients With Major Depressive Disorder In Japan
Official title: Clinical Evaluation of Bupropion SR (323U66)in Patients With Depression - Investigation in Elderly Patients With Depression
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Major Depressive Disorder (MDD)
Keywords: WELLBUTRIN
elderly
depression
Pharmacokinetics
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2006-05-29
Enrollment: 35
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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.

  * Major Depressive Disorder, Single Episode (296.2x) (excluding those with psychotic features)
  * Major Depressive Disorder, Recurrent (296.3x). (excluding those with psychotic features)
* 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:

  * Anorexia nervosa (DSM-IV-TR 307.1)
  * Bulimia nervosa (DSM-IV-TR 307.51)
* 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).

* Patients who have a history or complicated carcinoma or malignant tumour.
* Patients whose major depressive disorder is due to direct physiological effects of a general medical condition (for example, hypothyroidism, Parkinson's disease, chronic pain)
* Patients with systolic blood pressure of \>/=160 mmHg or diastolic blood pressure of \>/=100 mmHg at the start of the Treatment Period
* Patients diagnosed with dementia
* Patients who are inappropriate for participating in the study in the judgement of the investigator (sub-investigator).

Primary outcomes:
measure: Change From Baseline in Hamilton Rating Scale for Depression (HAM-D) Total Score at Week 8
timeFrame: Baseline and Week 8
Secondary outcomes:
measure: Percentage Change From Baseline in Hamilton Rating Scale for Depression (HAM-D) Total Score at Week 4
timeFrame: Baseline and Week 4
measure: Percentage Change From Baseline in Hamilton Rating Scale for Depression (HAM-D)Total Score at Week 8
timeFrame: Baseline and Week 8
measure: Percentage of Responders Based on the Hamilton Rating Scale for Depression (HAM-D) at Week 4
timeFrame: Week 4
measure: Percentage of Responders Based on the Hamilton Rating Scale for Depression (HAM-D) at Week 8
timeFrame: Week 8
measure: Percentage of Remitters Based on the Hamilton Rating Scale for Depression (HAM-D) at Week 4
timeFrame: Week 4
measure: Percentage of Remitters Based on the Hamilton Rating Scale for Depression (HAM-D) at Week 8
timeFrame: Week 8
measure: Change From Baseline in Hamilton Rating Scale for Depression (HAM-D) of Each Question's Score at Week 4
timeFrame: Baseline and Week 4
measure: Change From Baseline in Hamilton Rating Scale for Depression (HAM-D) for Each Question's Score at Week 8
timeFrame: Baseline and Week 8
measure: Percentage of Change From Baseline in Hamilton Rating Scale for Depression (HAM-D)for Each Question's Score at Week 4
timeFrame: Baseline and Week 4
measure: Percentage of Change From Baseline in Hamilton Rating Scale for Depression (HAM-D) for Each Question's Score at Week 8
timeFrame: Baseline and Week 8
measure: Hamilton Rating Scale for Depression (HAM-D) Total Score at Week 4 and Week 8
timeFrame: Week 4 and Week 8
measure: Percentage of Responders Based on the Clinical Global Impression - Global Improvement Score (CGI-I)at Week 4 and Week 8
timeFrame: Week 4 and Week 8
measure: Change From Baseline in Clinical Global Impression (CGI) Severity of Illness Score at Weeks 1, 2, 3, 4, 8
timeFrame: Baseline, Weeks 1, 2, 3, 4, 8
measure: Adverse Events (>=5% Incidence)
timeFrame: Baseline through Week 8
measure: Serious Adverse Events
timeFrame: Baseline through Week 8
Other outcomes:
Locations:
city: Fukuoka
country: Japan
facility: GSK Investigational Site
city: Fukushima
country: Japan
facility: GSK Investigational Site
city: Kumamoto
country: Japan
facility: GSK Investigational Site
city: Nagano
country: Japan
facility: GSK Investigational Site
city: Nagano
country: Japan
facility: GSK Investigational Site
city: Saitama
country: Japan
facility: GSK Investigational Site
city: Tokyo
country: Japan
facility: GSK Investigational Site
city: Tokyo
country: Japan
facility: GSK Investigational Site
city: Tokyo
country: Japan
facility: GSK Investigational Site
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials, MD
role: STUDY_DIRECTOR
References: