Phase 3
N=325
Study In Patients With Depression Not Responding to Selective Serotonin Re-uptake Inhibitors
Depressive Disorder
Bottom Line
View on ClinicalTrials.gov: NCT00296517 ↗Enrolled (actual)
325
Serious AEs
—
Results posted
Jul 2009
Primary outcome: Primary: Change From Baseline in the Hamilton Depression Scale (HAM-D 17 Items) Total Score — 19.8; 19.4; 14.7; 14.6 Score in scale — p=0.805
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- 323U66 (Bupropion Hydrochloride Sustained Release) (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- GlaxoSmithKline
- Primary completion
- Mar 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in the Hamilton Depression Scale (HAM-D 17 Items) Total Score |
19.8; 19.4; 14.7; 14.6; -5.1; -4.9 | 0.805 |
| SECONDARY Hamilton Depression Scale (HAM-D 17 Items) Total Score |
15.8; 15.4; 13.3; 12.1; 11.3; 10.3 | — |
| SECONDARY Change From Baseline in the Hamilton Depression Scale (HAM-D 17 Items) Total Score at Week 8 and Total Score at Week 12 |
-4.1; -4.0; -6.4; -7.4; -8.3; -9.2 | — |
| SECONDARY Percentage of Change From Baseline of the Hamilton Depression (HAM-D 17 Items) Total Score at Weeks 8 and 12. |
-21.0; -20.8; -33.2; -38.2; -26.5; -25.5 | — |
| SECONDARY Percentage of Responders Based on Hamilton Depression (HAM-D 17 Items) Scale Total Score at Weeks 8 and 12 |
24; 26; 31; 38; 37; 38 | — |
| SECONDARY Percentage of Remitters Based on Hamilton Depression (HAM-D 17 Items) Scale Total Score at Weeks 8 and 12 |
18; 18; 22; 26; 25; 24 | — |
| SECONDARY Change From Baseline in Each Item of the Hamilton Depression Scale (HAM-D 17 Items) Score at Weeks 8 and 12 |
-0.5; -0.5; -0.6; -0.6; -0.3; -0.3 | — |
| SECONDARY Percentage of Change From Baseline in Each Item of the Hamilton Depression Scale (HAM-D 17 Items) Score at Weeks 8 and 12 |
-17.7; -18.5; -25.9; -22.2; -24.9; -25.8 | — |
| SECONDARY Change From Baseline in Clinical Global Impressions - Severity of Illness (CGI-S) Scale at Weeks 1, 2, 3, 4, and 8 and 12 |
-0.0; 0.0; -0.1; -0.0; -0.1; -0.1 | — |
| SECONDARY Percentage of Responders Based on the Clinical Global Impression - Global Improvement (CGI-I) Scale at Weeks 8 and 12 |
33; 38; 42; 57; 44; 48 | — |
| SECONDARY Study Continuation Rate as Assessed by the Number of Participants at Risk at Week 12 |
102; 90; 55; 75 | 0.036 sig |
| SECONDARY Safety: Adverse Events by Organ System Class, Intensity, and Frequency |
32; 31; 8; 16; 1; 3 | — |
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).
Eligibility Criteria
Inclusion criteria
- [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.
- Age: >=18 years old (at the time of informed consent) , =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
Data sourced from ClinicalTrials.gov (NCT00296517). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.