Depressive DisorderPhase 3NCT00296517
Study In Patients With Depression Not Responding to Selective Serotonin Re-uptake Inhibitors
A Phase 3 study testing 323U66 (Bupropion Hydrochloride Sustained Release) in people with Depressive Disorder, run by GlaxoSmithKline at 62 sites in Japan.
Trial summary
This study is designed to evaluate the efficacy and safety in depressive patients who did not respond sufficiently to selective serotonin re-uptake inhibitors (SSRI). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Depressive Disorder
- What is being tested?
- 323U66 (Bupropion Hydrochloride Sustained Release)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 325 participants
- Where
- 62 sitesJapan
- Study dates
- 19 Jan 2006to 28 Mar 2008
- Phase
- Phase 3
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- [At the start of the pretreatment phase]
- Target disease: Patients diagnosed as having the following primary disease on the basis of DSM-IV-TR criteria.
- Major Depressive Disorder, Single Episode (296.2x) (excluding with psychotic features)
- Major Depressive Disorder, Recurrent (296.3x) (excluding with psychotic features)
- HAM-D (17 items) total score is >=16.
- Patients who have been treated with marketed paroxetine (Paxil®) at 20mg/day to 40mg/day for 4 weeks and more at the start of the pretreatment phase.
Show all 16Show fewer
- Age: >=18 years old (at the time of informed consent) , <65 years old (at the start of treatment phase )
- Gender: Male or female.
- Inpatients or outpatients: Either
- Informed consent: The subject himself/herself must give written informed consent. However, if the subject is under 20 at the time of giving consent, both the subject himself/herself and his/her legally acceptable representative must give written informed consent.
- [At the end of the pretreatment phase]
- HAM-D (17 items) total score is ≥14.
- Percentage of change from the start of the pretreatment phase in the HAM-D (17 items) total score is <50%
- [At the start of the treatment phase]
- HAM-D (17 items) total score is ≥14.
- Percentage of change from the start of the pretreatment phase in the HAM-D (17 items) total score is <50%
Who cannot join
- [At the start of the pre-treatment phase]
- Patients with a complication of glaucoma
- Patients concomitantly using a drug increasing the risk of bleeding and patients with bleeding tendency or predisposition to bleeding
- 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)
Show all 30Show fewer
- 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 formal cognitive behaviour therapy within 5 weeks prior to the start of the pre-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 pre-treatment phase
- Patients who have received electroconvulsive therapy within 17 weeks prior to the start of the pre-treatment phase
- Patients who have taken MAO inhibitors (selegiline hydrochloride) within 2 weeks prior to the start of the pre-treatment phase
- Patients who have taken another investigational drug within 12 weeks prior to the start of the pre-treatment phase
- Female patients who are pregnant, possibly pregnant or are nursing, and those who want to become pregnant before 30 days after the last dose of the investigational product
- Patients who have attempted suicide within 17 weeks prior to the start of the pre-treatment phase, or patients for whom the score of suicide-related item No. 3 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 and/or paroxetine
- Patients with serious cerebral disease
- Patients who have ECG or clinical evidence of any cardiac condition that the investigator (sub-investigator) feels may predispose the subject 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 with a history or complication of cancer 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
- Patients who are inappropriate for participating in the study in the judgement of the investigator (sub-investigator)
- [At the start of the treatment phase]
- Patients whose compliance of paroxetine during the pretreatment phase is less than 70%.
- Patients who have ECG or clinical evidence of any cardiac condition that the investigator (sub-investigator) feels may predispose the subject to ischemia or arrhythmia
- Patients with systolic blood pressure of >=160 mmHg or diastolic blood pressure of >=100 mmHg
Trial locations and contacts
62 sites in 1 country.
62 sites in 1 country
Japan62 sites
GSK Investigational Site
Aichi, 462-0831
GSK Investigational Site
Aichi, 470-1141
GSK Investigational Site
Aichi, 475-0074
GSK Investigational Site
Chiba, 270-1613
GSK Investigational Site
Fukuoka, 802-0006
GSK Investigational Site
Fukuoka, 810-0001
GSK Investigational Site
Fukuoka, 814-0180
GSK Investigational Site
Fukuoka, 816-0801
GSK Investigational Site
Fukuoka, 816-0864
GSK Investigational Site
Fukushima, 960-0102
GSK Investigational Site
Fukushima, 961-0021
GSK Investigational Site
Fukushima, 963-0207
GSK Investigational Site
Hokkaido, 002-8029
GSK Investigational Site
Hokkaido, 004-0052
GSK Investigational Site
Hokkaido, 004-0841
GSK Investigational Site
Hokkaido, 047-0155
GSK Investigational Site
Hokkaido, 060-0042
GSK Investigational Site
Hokkaido, 060-0061
GSK Investigational Site
Hokkaido, 062-0922
GSK Investigational Site
Hokkaido, 063-0061
GSK Investigational Site
Hokkaido, 063-0804
GSK Investigational Site
Hokkaido, 080-0014
GSK Investigational Site
Hyōgo, 651-0092
GSK Investigational Site
Hyōgo, 651-0097
GSK Investigational Site
Hyōgo, 653-0841
GSK Investigational Site
Hyōgo, 657-0846
GSK Investigational Site
Ibaraki, 300-0812
GSK Investigational Site
Ibaraki, 311-3193
GSK Investigational Site
Ishikawa, 920-0939
GSK Investigational Site
Kagawa, 761-0793
GSK Investigational Site
Kanagawa, 213-0001
GSK Investigational Site
Kanagawa, 223-0052
GSK Investigational Site
Kanagawa, 225-0011
GSK Investigational Site
Kanagawa, 231-0023
GSK Investigational Site
Kanagawa, 238-0042
GSK Investigational Site
Kumamoto, 861-8002
GSK Investigational Site
Nagano, 390-8510
GSK Investigational Site
Nara, 639-0225
GSK Investigational Site
Okayama, 700-0941
GSK Investigational Site
Osaka, 530-0026
GSK Investigational Site
Osaka, 571-0048
GSK Investigational Site
Osaka, 576-0054
GSK Investigational Site
Osaka, 582-0025
GSK Investigational Site
Osaka, 589-0011
GSK Investigational Site
Osaka, 590-0018
GSK Investigational Site
Tokyo, 107-0052
GSK Investigational Site
Tokyo, 108-0072
GSK Investigational Site
Tokyo, 110-0005
GSK Investigational Site
Tokyo, 114-0014
GSK Investigational Site
Tokyo, 120-0033
GSK Investigational Site
Tokyo, 141-0032
GSK Investigational Site
Tokyo, 152-0012
GSK Investigational Site
Tokyo, 154-0003
GSK Investigational Site
Tokyo, 154-0004
GSK Investigational Site
Tokyo, 160-0023
GSK Investigational Site
Tokyo, 170-0002
GSK Investigational Site
Tokyo, 170-0005
GSK Investigational Site
Tokyo, 178-0063
GSK Investigational Site
Tokyo, 194-0022
GSK Investigational Site
Tokyo, 204-0022
GSK Investigational Site
Tottori, 682-0023
GSK Investigational Site
Tottori, 683-8504
About this study
Official title: Clinical Evaluation of 323U66 SR in Patients With Depression - Placebo-controlled, Double-blind, Comparative Study in Patients With Depression Who Did Not Respond Sufficiently to Selective Serotonin Re-uptake Inhibitors
This study is designed to evaluate the efficacy and safety in depressive patients who did not respond sufficiently to selective serotonin re-uptake inhibitors (SSRI).
- Conditions
- Depressive Disorder
- Being tested
- 323U66 (Bupropion Hydrochloride Sustained Release), Placebo
- Keywords
- depression, double-blind, placebo-controlled, bupropion hydrochloride, SSRI, comparative study, non-responder
- Medical subject headings
- Depressive Disorder, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
323U66 (Bupropion Hydrochloride Sustained Release)Drug
Subjects with Major Depressive Disorder who were randomized to take 100mg of Bupropion SR in the morning and placebo in the evening for one week. Week 2 subjects were given 100mg dose of Bupropion morning and evening. Weeks 3 thru 12 received 150mg dose morning and evening. Week 1=dose level 1, 100 mg. Week 2=dose level 2, 200 mg. Weeks 3 - 12=dose level 3, 300 mg.
PlaceboDrug
Subjects with Major Depressive Disorder who were randomised to placebo to match Bupropion SR during the treatment period.
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Subjects with Major Depressive Disorder who were randomised to placebo to match Bupropion SR during the treatment period. Receives: Drug: Placebo |
| Bupropion SR | Experimental | Subjects with Major Depressive Disorder who were randomized to take 100mg of Bupropion SR in the morning and placebo in the evening for one week. Week 2 subjects were given 100mg dose of Bupropion morning and evening. Weeks 3 thru 12 received 150mg dose morning and evening. Week 1=dose level 1, 100 mg. Week 2=dose level 2, 200 mg. Weeks 3 - 12=dose level 3, 300 mg. Receives: Drug: 323U66 (Bupropion Hydrochloride Sustained Release) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in the Hamilton Depression Scale (HAM-D 17 Items) Total Score
The Hamilton Rating Scale for Depression 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 52 (severely ill).
Measured: Baseline and Week 12
Secondary outcomes (11)
Hamilton Depression Scale (HAM-D 17 Items) Total Score
The Hamilton Rating Scale for Depression 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 52 (severely ill).
Measured: Week 8 and Week 12
Change From Baseline in the Hamilton Depression Scale (HAM-D 17 Items) Total Score at Week 8 and Total Score at Week 12
The Hamilton Rating Scale for Depression 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 52 (severely ill).
Measured: Baseline to Week 8 and Week 12
Percentage of Change From Baseline of the Hamilton Depression (HAM-D 17 Items) Total Score at Weeks 8 and 12.
The Hamilton Rating Scale for Depression 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 52 (severely ill).
Measured: Baseline to Week 8 and Week 12
Percentage of Responders Based on Hamilton Depression (HAM-D 17 Items) Scale Total Score at Weeks 8 and 12
The Hamilton Rating Scale for Depression 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 52 (severely ill). Responders are defined as subjects with 50% or greater reduction from baseline in HAM-D total score.
Measured: Baseline to Week 8 and Week 12
Percentage of Remitters Based on Hamilton Depression (HAM-D 17 Items) Scale Total Score at Weeks 8 and 12
The Hamilton Rating Scale for Depression 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 52 (severely ill). Remitters are defined as subjects with HAM-D total score ≤ 7.
Measured: Baseline to Week 8 and Week 12
Change From Baseline in Each Item of the Hamilton Depression Scale (HAM-D 17 Items) Score at Weeks 8 and 12
The Hamilton Rating Scale for Depression 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 scores ranging from 0 (not ill) to 54 (severely ill).
Measured: Baseline to Week 8 and Week 12
Percentage of Change From Baseline in Each Item of the Hamilton Depression Scale (HAM-D 17 Items) Score at Weeks 8 and 12
The Hamilton Rating Scale for Depression 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 scores ranging from 0 (not ill) to 54 (severely ill).
Measured: Baseline to Week 8 and Week 12
Change From Baseline in Clinical Global Impressions - Severity of Illness (CGI-S) Scale at Weeks 1, 2, 3, 4, and 8 and 12
The 7-point Clinical Global Impressions-Severity of Illness Scale (CGI-S) measures the severity of psychiatric symptoms. The following scores can be given: 1 = normal, not at all ill; 2 = borderline mentally ill; 3 = mildly ill; 4 = moderately ill; 5 = markedly ill; 6 = severely ill; 7 = among the most extremely ill patients.
Measured: Baseline to Weeks 1, 2, 3, 4, 8, and 12
Percentage of Responders Based on the Clinical Global Impression - Global Improvement (CGI-I) Scale at Weeks 8 and 12
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: Baseline to Week 8 and Week 12
Study Continuation Rate as Assessed by the Number of Participants at Risk at Week 12
Kaplan-Meier estimates were calculated using event or censoring and time to event or censoring. Participants at risk refers to participants with either a censoring or event time beyond the time point of interest (Week 12).
Measured: Week 12
Safety: Adverse Events by Organ System Class, Intensity, and Frequency
Assessment of intensity was based on investigators/subinvestigator's clinical judgement per protocol instructions: Mild event, easily tolerated, with minimal discomfort and not interfering with Activities of Daily Living (ADLs); moderate event, with discomfort that interferes with ADLs; severe event, prevents ADLs.
Measured: Baseline to Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2006 (estimated)
- Study start19 Jan 2006
- Primary completion28 Mar 2008
- Study completion28 Mar 2008
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 Depressive DisorderStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 325 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00296517
- Sponsor's protocol ID
- AK1102365
- Status last verified
- Nov 2019
- First submitted
- 23 Feb 2006
- Last updated
- 4 Dec 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Individual data sharing
- Yes: IPD for this study will be made available via the Clinical Study Data Request site.
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation of 323U66 SR in Patients With Depression - Placebo-controlled, Double-blind, Comparative Study in Patients With Depression Who Did Not Respond Sufficiently to Selective Serotonin Re-uptake Inhibitors
- ClinicalTrials.gov ID
- NCT00296517
- Acronym / sponsor ID
- AK1102365
- Conditions
- Depressive Disorder
- Keywords
- depression, double-blind, placebo-controlled, bupropion hydrochloride, SSRI, comparative study, non-responder
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 325 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- 19 Jan 2006 (actual)
- Primary completion
- 28 Mar 2008 (actual)
- Study completion
- 28 Mar 2008 (actual)
- First posted
- 27 Feb 2006 (estimated)
- Results
- Posted 16 Jul 2009
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is designed to evaluate the efficacy and safety in depressive patients who did not respond sufficiently to selective serotonin re-uptake inhibitors (SSRI).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: PlaceboSubjects with Major Depressive Disorder who were randomised to placebo to match Bupropion SR during the treatment period. |
| Bupropion SR | Experimental | Drug: 323U66 (Bupropion Hydrochloride Sustained Release)Subjects with Major Depressive Disorder who were randomized to take 100mg of Bupropion SR in the morning and placebo in the evening for one week. Week 2 subjects were given 100mg dose of Bupropion morning and evening. Weeks 3 thru 12 received 150mg dose morning and evening. Week 1=dose level 1, 100 mg. Week 2=dose level 2, 200 mg. Weeks 3 - 12=dose level 3, 300 mg. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- [At the start of the pretreatment phase]
- Target disease: Patients diagnosed as having the following primary disease on the basis of DSM-IV-TR criteria.
- Major Depressive Disorder, Single Episode (296.2x) (excluding with psychotic features)
- Major Depressive Disorder, Recurrent (296.3x) (excluding with psychotic features)
- HAM-D (17 items) total score is >=16.
Key exclusion criteria (30 listed)
- [At the start of the pre-treatment phase]
- Patients with a complication of glaucoma
- Patients concomitantly using a drug increasing the risk of bleeding and patients with bleeding tendency or predisposition to bleeding
- 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:
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 (Bupropion Hydrochloride Sustained Release)Subjects with Major Depressive Disorder who were randomized to take 100mg of Bupropion SR in the morning and placebo in the evening for one week. Week 2 subjects were given 100mg dose of Bupropion morning and evening. Weeks 3 thru 12 received 150mg dose morning and evening. Week 1=dose level 1, 100 mg. Week 2=dose level 2, 200 mg. Weeks 3 - 12=dose level 3, 300 mg. | Drug | Bupropion SR |
| PlaceboSubjects with Major Depressive Disorder who were randomised to placebo to match Bupropion SR during the treatment period. | Drug | Placebo |
Primary outcome
Change From Baseline in the Hamilton Depression Scale (HAM-D 17 Items) Total Score
Time frame: Baseline and Week 12
The Hamilton Rating Scale for Depression 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 52 (severely ill).
11 secondary outcomes
Hamilton Depression Scale (HAM-D 17 Items) Total Score
Time frame: Week 8 and Week 12
Change From Baseline in the Hamilton Depression Scale (HAM-D 17 Items) Total Score at Week 8 and Total Score at Week 12
Time frame: Baseline to Week 8 and Week 12
Percentage of Change From Baseline of the Hamilton Depression (HAM-D 17 Items) Total Score at Weeks 8 and 12.
Time frame: Baseline to Week 8 and Week 12
Percentage of Responders Based on Hamilton Depression (HAM-D 17 Items) Scale Total Score at Weeks 8 and 12
Time frame: Baseline to Week 8 and Week 12
Percentage of Remitters Based on Hamilton Depression (HAM-D 17 Items) Scale Total Score at Weeks 8 and 12
Time frame: Baseline to Week 8 and Week 12
Change From Baseline in Each Item of the Hamilton Depression Scale (HAM-D 17 Items) Score at Weeks 8 and 12
Time frame: Baseline to Week 8 and Week 12
Percentage of Change From Baseline in Each Item of the Hamilton Depression Scale (HAM-D 17 Items) Score at Weeks 8 and 12
Time frame: Baseline to Week 8 and Week 12
Change From Baseline in Clinical Global Impressions - Severity of Illness (CGI-S) Scale at Weeks 1, 2, 3, 4, and 8 and 12
Time frame: Baseline to Weeks 1, 2, 3, 4, 8, and 12
Percentage of Responders Based on the Clinical Global Impression - Global Improvement (CGI-I) Scale at Weeks 8 and 12
Time frame: Baseline to Week 8 and Week 12
Study Continuation Rate as Assessed by the Number of Participants at Risk at Week 12
Time frame: Week 12
Safety: Adverse Events by Organ System Class, Intensity, and Frequency
Time frame: Baseline to Week 12
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. IPD for this study will be made available via the Clinical Study Data Request site.
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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 study director
GlaxoSmithKline
62 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing 323U66 (Bupropion Hydrochloride Sustained Release) in people with Depressive Disorder, run by GlaxoSmithKline at 62 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 16 inclusion and 30 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 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 62 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. Some participants in this study may receive a placebo. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 16 Jul 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 the Hamilton Depression Scale (HAM-D 17 Items) Total Score (time frame: Baseline and Week 12). 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 Dec 2019; AzTrials last refreshed its copy on 31 Oct 2026.