Last updated: 07/17/2024 17:47:08
Study In Patients With Depression Not Responding to Selective Serotonin Re-uptake Inhibitors
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Completed
Completed
Trial overview
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
Trial description: 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).
Primary purpose:
Treatment
Trial design:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Allocation:
Randomized
Primary outcomes:
Change from baseline in the Hamilton Depression Scale (HAM-D 17 items) total score
Timeframe: Baseline and Week 12
Secondary outcomes:
Hamilton Depression Scale (HAM-D 17 items) total score
Timeframe: 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
Timeframe: 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.
Timeframe: 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
Timeframe: 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
Timeframe: 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
Timeframe: 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
Timeframe: 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
Timeframe: 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
Timeframe: Baseline to Week 8 and Week 12
Study Continuation Rate as assessed by the number of participants at risk at Week 12
Timeframe: Week 12
Safety: Adverse events by Organ System Class, Intensity, and Frequency
Timeframe: Baseline to Week 12
Interventions:
Drug: 323U66 (Bupropion Hydrochloride Sustained Release)
Drug: Placebo
Enrollment:
325
Observational study model:
Not applicable
Primary completion date:
2008-28-03
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Depressive Disorder
Product
bupropion, paroxetine
Collaborators
Not applicable
Study date(s)
January 2006 to March 2008
Type
Interventional
Phase
3
Participation criteria
Sex
Female & Male
Age
18 - 65 years
Accepts healthy volunteers
No
- [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.
- [At the start of the pre-treatment phase]
- Patients with a complication of glaucoma
Inclusion and exclusion 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) , <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] 1. HAM-D (17 items) total score is ≥14. 2. 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] 1. HAM-D (17 items) total score is ≥14. 2. Percentage of change from the start of the pretreatment phase in the HAM-D (17 items) total score is <50%
Exclusion criteria:
- [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)
- 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] 1. Patients whose compliance of paroxetine during the pretreatment phase is less than 70%. 2. 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 3. Patients with systolic blood pressure of >=160 mmHg or diastolic blood pressure of >=100 mmHg
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
2008-28-03
Actual study completion date
2008-28-03
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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