Study Of Bupropion SR (323U66) In Patients With Major Depressive Disorder In Japan

Major Depressive Disorder (MDD) Clinical Trial

Official title:

Clinical Evaluation of Bupropion SR (323U66)in Patients With Depression - Investigation in Elderly Patients With Depression

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00330616
• Other study ID #: AK1102369
• Status: Completed
• Phase: Phase 2
• First received: May 26, 2006
• Last updated: April 13, 2015
• Start date: May 2006
• Est. completion date: November 2007

Study information

• Verified date: June 2009
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Ministry of Health, Labor and Welfare
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 35
• Est. completion date: November 2007
• Est. primary completion date: November 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 65 Years and older

Eligibility

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).

Study Design

Endpoint Classification: Safety/Efficacy Study, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Major
• Major Depressive Disorder (MDD)

Intervention

Drug:
• 323U66 SR

Locations

Country	Name	City	State
Japan	GSK Investigational Site	Fukuoka
Japan	GSK Investigational Site	Fukushima
Japan	GSK Investigational Site	Kumamoto
Japan	GSK Investigational Site	Nagano
Japan	GSK Investigational Site	Nagano
Japan	GSK Investigational Site	Saitama
Japan	GSK Investigational Site	Tokyo
Japan	GSK Investigational Site	Tokyo
Japan	GSK Investigational Site	Tokyo

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change From Baseline in Hamilton Rating Scale for Depression (HAM-D) Total Score at Week 8	The Hamilton Rating Scale for Depression (HAM D) contains 17 questions which detect change and measure illness severity. Individual items are rated on a scale of 0-4, 0-3, and 0-2 with total HAM D score range from 0 (not ill) to 53 (severely ill).	Baseline and Week 8	No
Secondary	Percentage Change From Baseline in Hamilton Rating Scale for Depression (HAM-D) Total Score at Week 4	The Hamilton Rating Scale for Depression (HAM D)contains 17 questions which detect change and measure illness severity. Individual items are rated on a scale of 0-4, 0-3, and 0-2 with total HAM D score range from 0 (not ill) to 53 (severely ill).	Baseline and Week 4	No
Secondary	Percentage Change From Baseline in Hamilton Rating Scale for Depression (HAM-D)Total Score at Week 8	The Hamilton Rating Scale for Depression (HAM D)contains 17 questions which detect change and measure illness severity. Individual items are rated on a scale of 0-4, 0-3, and 0-2 with total HAM D score range from 0 (not ill) to 53 (severely ill).	Baseline and Week 8	No
Secondary	Percentage of Responders Based on the Hamilton Rating Scale for Depression (HAM-D) at Week 4	The Hamilton Rating Scale for Depression (HAM D)contains 17 questions which detect change and measure illness severity. Individual items are rated on a scale of 0-4, 0-3, and 0-2 with total HAM D score range from 0 (not ill) to 53 (severely ill). Responders are defined as subjects that had a decrease of >/= 50% total score on the HAM D.	Week 4	No
Secondary	Percentage of Responders Based on the Hamilton Rating Scale for Depression (HAM-D) at Week 8	The Hamilton Rating Scale for Depression (HAM D)contains 17 questions which detect change and measure illness severity. Individual items are rated on a scale of 0-4, 0-3, and 0-2 with total HAM D score range from 0 (not ill) to 53 (severely ill). Responders are defined as subjects that had a decrease of >/= 50% total score on the HAM D.	Week 8	No
Secondary	Percentage of Remitters Based on the Hamilton Rating Scale for Depression (HAM-D) at Week 4	The Hamilton Rating Scale for Depression (HAM D)contains 17 questions which detect change and measure illness severity. Individual items are rated on a scale of 0-4, 0-3, and 0-2 with total HAM D score range from 0 (not ill) to 53 (severely ill). Remitters are defined as subjects with a HAM D total score of	Week 4	No
Secondary	Percentage of Remitters Based on the Hamilton Rating Scale for Depression (HAM-D) at Week 8	The Hamilton Rating Scale for Depression (HAM D)contains 17 questions which detect change and measure illness severity. Individual items are rated on a scale of 0-4, 0-3, and 0-2 with total HAM D score range from 0 (not ill) to 53 (severely ill). Remitters are defined as subjects with a HAM D total score of	Week 8	No
Secondary	Change From Baseline in Hamilton Rating Scale for Depression (HAM-D) of Each Question's Score at Week 4	The Hamilton Rating Scale for Depression (HAM D)contains 17 questions which detect change and measure illness severity. Individual items are rated on a scale of 0-4, 0-3, and 0-2 with total HAM D score range from 0 (not ill) to 53 (severely ill).	Baseline and Week 4	No
Secondary	Change From Baseline in Hamilton Rating Scale for Depression (HAM-D) for Each Question's Score at Week 8	The Hamilton Rating Scale for Depression (HAM D)contains 17 questions which detect change and measure illness severity. Individual items are rated on a scale of 0-4, 0-3, and 0-2 with total HAM D score range from 0 (not ill) to 53 (severely ill).	Baseline and Week 8	No
Secondary	Percentage of Change From Baseline in Hamilton Rating Scale for Depression (HAM-D)for Each Question's Score at Week 4	The Hamilton Rating Scale for Depression (HAM-D)contains 17 questions which detect change and measure illness severity. Individual items are rated on a scale of 0-4, 0-3, and 0-2 with total HAM-D score range from 0 (not ill) to 53 (severely ill).	Baseline and Week 4	No
Secondary	Percentage of Change From Baseline in Hamilton Rating Scale for Depression (HAM-D) for Each Question's Score at Week 8	The Hamilton Rating Scale for Depression (HAM-D)contains 17 questions which detect change and measure illness severity. Individual items are rated on a scale of 0-4, 0-3, and 0-2 with total HAM D score range from 0 (not ill) to 53 (severely ill).	Baseline and Week 8	No
Secondary	Hamilton Rating Scale for Depression (HAM-D) Total Score at Week 4 and Week 8	The Hamilton Rating Scale for Depression (HAM-D)contains 17 questions which detect change and measure illness severity. Individual items are rated on a scale of 0-4, 0-3, and 0-2 with total HAM D score range from 0 (not ill) to 53 (severely ill).	Week 4 and Week 8	No
Secondary	Percentage of Responders Based on the Clinical Global Impression - Global Improvement Score (CGI-I)at Week 4 and Week 8	The CGI-I assesses the investigator's impression of the patient's current illness. The time span is the week before the rating and the score ranges from 1 (very much improved) to 7 (very much worse). Responders are subjects that have a score of 1 (very much improved) or 2 (much improved) on the CGI-I.	Week 4 and Week 8	No
Secondary	Change From Baseline in Clinical Global Impression (CGI) Severity of Illness Score at Weeks 1, 2, 3, 4, 8	The CGI-S assesses the investigator's impression of the severity of the patient's current illness. The time span is the week before the rating and the score ranges from 1 (normal, not at all ill) to 7 (among the most extremely ill patients).	Baseline, Weeks 1, 2, 3, 4, 8	No
Secondary	Adverse Events (>=5% Incidence)		Baseline through Week 8	No
Secondary	Serious Adverse Events		Baseline through Week 8	No