Major Depressive Disorder (MDD)Phase 2NCT00330616
Study Of Bupropion SR (323U66) In Patients With Major Depressive Disorder In Japan
A Phase 2 study testing 323U66 SR in people with Major Depressive Disorder (MDD), run by GlaxoSmithKline at 9 sites in Japan.
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. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Major Depressive Disorder (MDD)
- What is being tested?
- 323U66 SR
- How many people
- 35 participants
- Where
- 9 sitesJapan
- Study dates
- May 2006to Nov 2007
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 24Show fewer
- 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).
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
Japan9 sites
GSK Investigational Site
Fukuoka, 815-0041
GSK Investigational Site
Fukushima, 961-0021
GSK Investigational Site
Kumamoto, 861-8002
GSK Investigational Site
Nagano, 395-0056
GSK Investigational Site
Nagano, 399-8695
GSK Investigational Site
Saitama, 332-0012
GSK Investigational Site
Tokyo, 164-0012
GSK Investigational Site
Tokyo, 170-0002
GSK Investigational Site
Tokyo, 189-0012
About this study
Official title: 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.
- Conditions
- Major Depressive Disorder (MDD)
- Being tested
- 323U66 SR
- Keywords
- WELLBUTRIN, elderly, depression, Pharmacokinetics
- Medical subject headings
- Depressive Disorder, Major, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
323U66 SRDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Baseline and Week 8
Secondary outcomes (15)
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).
Measured: Baseline and Week 4
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).
Measured: Baseline and Week 8
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.
Measured: Week 4
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.
Measured: Week 8
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 </= 7.
Measured: Week 4
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 </= 7.
Measured: Week 8
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).
Measured: Baseline and Week 4
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).
Measured: Baseline and Week 8
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).
Measured: Baseline and Week 4
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).
Measured: Baseline and Week 8
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).
Measured: Week 4 and Week 8
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.
Measured: Week 4 and Week 8
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).
Measured: Baseline, Weeks 1, 2, 3, 4, 8
Adverse Events (>=5% Incidence)
Measured: Baseline through Week 8
Serious Adverse Events
Measured: Baseline through Week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2006 (estimated)
- Study startMay 2006
- Primary completionNov 2007
- Study completionNov 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Major Depressive Disorder (MDD)Studies of the same condition, open and under way.
- More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Masking
- None (open label)
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- GSK Clinical Trials, MD, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00330616
- Sponsor's protocol ID
- AK1102369
- Status last verified
- Jun 2009
- First submitted
- 26 May 2006
- Last updated
- 4 May 2015
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation of Bupropion SR (323U66)in Patients With Depression - Investigation in Elderly Patients With Depression
- ClinicalTrials.gov ID
- NCT00330616
- Acronym / sponsor ID
- AK1102369
- Conditions
- Major Depressive Disorder (MDD)
- Keywords
- WELLBUTRIN, elderly, depression, Pharmacokinetics
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- May 2006
- Primary completion
- Nov 2007 (actual)
- Study completion
- Nov 2007 (actual)
- First posted
- 29 May 2006 (estimated)
- Results
- Posted 20 Mar 2009
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Masking
- None (open label)
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (24 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 323U66 SR | Drug | – |
Primary outcome
Change From Baseline in Hamilton Rating Scale for Depression (HAM-D) Total Score at Week 8
Time frame: Baseline 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).
15 secondary outcomes
Percentage Change From Baseline in Hamilton Rating Scale for Depression (HAM-D) Total Score at Week 4
Time frame: Baseline and Week 4
Percentage Change From Baseline in Hamilton Rating Scale for Depression (HAM-D)Total Score at Week 8
Time frame: Baseline and Week 8
Percentage of Responders Based on the Hamilton Rating Scale for Depression (HAM-D) at Week 4
Time frame: Week 4
Percentage of Responders Based on the Hamilton Rating Scale for Depression (HAM-D) at Week 8
Time frame: Week 8
Percentage of Remitters Based on the Hamilton Rating Scale for Depression (HAM-D) at Week 4
Time frame: Week 4
Percentage of Remitters Based on the Hamilton Rating Scale for Depression (HAM-D) at Week 8
Time frame: Week 8
Change From Baseline in Hamilton Rating Scale for Depression (HAM-D) of Each Question's Score at Week 4
Time frame: Baseline and Week 4
Change From Baseline in Hamilton Rating Scale for Depression (HAM-D) for Each Question's Score at Week 8
Time frame: Baseline and Week 8
Percentage of Change From Baseline in Hamilton Rating Scale for Depression (HAM-D)for Each Question's Score at Week 4
Time frame: Baseline and Week 4
Percentage of Change From Baseline in Hamilton Rating Scale for Depression (HAM-D) for Each Question's Score at Week 8
Time frame: Baseline and Week 8
Hamilton Rating Scale for Depression (HAM-D) Total Score at Week 4 and Week 8
Time frame: Week 4 and Week 8
Percentage of Responders Based on the Clinical Global Impression - Global Improvement Score (CGI-I)at Week 4 and Week 8
Time frame: Week 4 and Week 8
Change From Baseline in Clinical Global Impression (CGI) Severity of Illness Score at Weeks 1, 2, 3, 4, 8
Time frame: Baseline, Weeks 1, 2, 3, 4, 8
Adverse Events (>=5% Incidence)
Time frame: Baseline through Week 8
Serious Adverse Events
Time frame: Baseline through Week 8
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
GSK Clinical Trials, MD study director
GlaxoSmithKline
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing 323U66 SR in people with Major Depressive Disorder (MDD), run by GlaxoSmithKline at 9 sites in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 May 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 20 Mar 2009). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change From Baseline in Hamilton Rating Scale for Depression (HAM-D) Total Score at Week 8 (time frame: Baseline and Week 8). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 May 2015.