Last updated: 11/04/2018 04:34:55
Study Of 323U66 SR In Major Depressive Disorder
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Completed
Completed
Trial overview
Official title: An Open-Label, Multi-Center, Phase II Study Evaluating the Safety and Efficacy of 323U66 SR in Patients with Depression
Trial description: This study was designed to evaluate the efficacy and safety in major depressive disorder patients.
Primary purpose:
Treatment
Trial design:
Single Group Assignment
Masking:
None (Open Label)
Allocation:
Non-randomized
Primary outcomes:
Change from Baseline in the Montgomery-Asberg depression rating scale (MADRS) total score at Week 8 in observed cases
Timeframe: Baseline (Week 0) and Week 8
Secondary outcomes:
Change from Baseline in the MADRS total score at Week 52 in observed cases
Timeframe: Baseline (Week 0) and Week 52
Change from Baseline in the Hamilton depression rating scale (HAM-D; 17 items) total score at Weeks 8 and 52 in observed cases
Timeframe: Baseline (Week 0) and Week 8, 52
Percentage of participants who were Clinical Global Impression global improvement (CGI-I) responders at Weeks 8 and 52 in observed cases
Timeframe: Week 8, 52
Change from Baseline in CGI severity of illness (CGI-SI) at Weeks 8 and 52 in observed cases
Timeframe: Baseline (Week 0) and Week 8, 52
Change from Baseline in the Sheehan Disability Scale (SDISS) total score at Weeks 8 and 52 in observed cases
Timeframe: Baseline (Week 0) and Week 8, 52
Change from Baseline in the Motivation Energy Inventory Short Form (MEI-SF) total score at Weeks 8 and 52 in observed cases
Timeframe: Baseline (Week 0) and Week 8, 52
Interventions:
Drug: bupropion hydrochloride
Enrollment:
234
Observational study model:
Not applicable
Primary completion date:
2007-28-05
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Depressive Disorder
Product
bupropion
Collaborators
Not applicable
Study date(s)
December 2004 to May 2007
Type
Interventional
Phase
2
Participation criteria
Sex
Female & Male
Age
18 - 64 years
Accepts healthy volunteers
No
- Met DSM-IV-TR criteria for major depressive disorder for their current episode for at least 8 weeks prior to screening visit.
- Must give a written informed consent. But if the patient is under 20, both the patient himself/herself and his/her proxy consenter must give written informed consent.
- Current or past history of seizure disorder or brain injury.
- Current or past history of anorexia or bulimia nervosa.
Inclusion and exclusion criteria
Inclusion criteria:
- Met DSM-IV-TR criteria for major depressive disorder for their current episode for at least 8 weeks prior to screening visit.
- Must give a written informed consent. But if the patient is under 20, both the patient himself/herself and his/her proxy consenter must give written informed consent.
- Must have rating scores as outlined.
Exclusion criteria:
- Current or past history of seizure disorder or brain injury.
- Current or past history of anorexia or bulimia nervosa.
- History of manic episode.
- Past or current DSM- IV-TR diagnosis of schizophrenia or other psychotic disorder.
- Diagnosis of substance abuse (alcohol or drug) by the DSM-IV-TR criteria.
- Pregnant, possibly pregnant or lactating.
- Must not be suicidal.
- Blood pressure of SBP>160mmHg, DBP>100mmHg.
- History or complication of cancer or malignant tumour.
Trial location(s)
Study documents
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Results posted on ClinicalTrials.gov
Recruitment status
Completed
Actual primary completion date
2007-28-05
Actual study completion date
2007-28-05
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
Additional information about the trial
Additional information
Not applicable
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