| Primary | Mean Change in Hamilton Depression Rating Scale - 17 (HAMD-17) Total Score From Baseline to End of Acute Treatment Phase (Week 8) | HAMD-17 is used to assess the severity of depression and symptom improvement. It consisted of 17 questions. The HAMD-17 total score is calculated by summing the individual response scores if there is no missing response. HAMD-17 has a total score in a range of 0 (not present) to 52 (severe). Change from Baseline was calculated by subtracting the Baseline total score (at Day 0, Week 0) from Week 8 observed total score. The Per Protocol (PP) Population is defined as all randomized participants in the Intent-To-Treat (ITT) Population who do not meet criteria of a major protocol deviation, with overall compliance of active drug for acute treatment phase in the range of 75%-125% and complete the first 6 weeks treatment and has HAMD-17 assessment at/after week 6 (that is >=35 days). All participants in the PP population were included in the mixed model repeated measures analysis. Only those participants with data available at the specified time point were analyzed. | | Posted | | Least Squares Mean | Standard Error | Scores on a scale | | Baseline (Week 0) and Week 8 | | | | ID | Title | Description |
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| OG000 | Bupropion XL | In a double-blind 8-week acute treatment phase, participants received 1 tablet of bupropion XL 150 milligram (mg) per day at dose level 1 (Week 0 to Week 1). At dose level 2 (Week 1 to Week 4), bupropion XL dose was increased to 300 mg per day (2 tablets of bupropion XL 150 mg) for further 3 weeks to ensure that participants had achieved the clinical recommended dose. At dose level 3 (Week 4 to Week 8), bupropion XL dose was still maintained at 300 mg per day (2 tablets of bupropion XL 150 mg). To ensure study blind, the participants were dosed with placebo matching escitalopram at each dose level. After treatment phase, participants entered in taper phase where dose in was down-titrated step by step to reduce the possible withdrawal symptoms. In taper phase, both dose level 2 and dose level 3 were down titrated to dose level 1 for 1 week before discontinuation. | | OG001 | Escitalopram | In a double-blind 8-week acute treatment phase, participants received 1 capsule of escitalopram 10 mg per day at dose level 1 (Week 0 to Week 1). Escitalopram dose was maintained at 10 mg per day (1 capsule of Escitalopram 10 mg) for further 3 weeks to ensure that participants had achieved the clinical recommended dose. At dose level 3 (Week 4 to Week 8), the escitalopram dose could be increased to 20 mg per day (2 capsule of Escitalopram 10 mg). To ensure study blind, the participants were also dosed with placebo matching bupropion XL at each dose level. After treatment phase, participants entered in taper phase where dose in was down-titrated step by step to reduce the possible withdrawal symptoms. In taper phase, both dose level 2 and dose level 3 were down titrated to dose level 1 for 1 week before discontinuation. |
| | | Title | Denominators | Categories |
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| | | Title | Measurements |
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| - OG000-14.5± 0.41
- OG001-15.4± 0.39
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| | Group IDs | Group Description | Statistical Method | Statistical Comment | P-Value | P-Value Comment | Parameter Type | Parameter Value | Dispersion Type | Dispersion Value | Confidence Interval Sides | Confidence Interval % | CI Lower Limit | CI Upper Limit | CI Lower Limit Comment | CI Upper Limit Comment | Estimate Comment | Tested Non-Inferiority | Non-Inferiority Type | Non-Inferiority Comment | Other Analysis Description |
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| | Mixed model repeated measures analysis | | 0.139 | Analysis included Baseline HAMD-17 total score as covariate, treatment, gender, visit and treatment-visit interaction as fixed effects. Unstructured covariance matrix was used. | Mean Difference (Final Values) | 0.8 | | | 2-Sided | 95 | -0.27 | 1.94 | | | Observed Cases (OC) dataset was used, where available data at a given time point was used with no missing values filled in with estimates. | | Non-Inferiority | A one-sided 97.5% confidence interval for the between-treatment difference (bupropion XL-escitalopram) was compared with the pre-defined non-inferiority margin of 2.2. If the upper limit of the one-sided 97.5% confidence interval was below 2.2, then it indicated that bupropion was not inferior in efficacy to escitalopram. |
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| Secondary | Response Rate Based on HAMD-17 Total Score | HAMD-17 is an extensively used tool to assess the severity of depression and symptom improvement during the treatment. The HAMD-17 adopted for this study consisted of 17 questions with multiple choice responses, each of which is numerically scored. The HAMD-17 total score is calculated by summing the individual response scores if there is no missing response. HAMD-17 has a total score in a range of 0 (not present) to 52 (severe). Values at Day 0, Week 0 was considered as Baseline value. Response was defined as decrease in HAMD-17 total scores at end of acute treatment phase (Week 8) relative to Baseline by at least 50%. Non-responder Imputation was used in calculation of rates. | | Posted | | Number | | Percentage of Participants | | Up to Week 8 | | | | ID | Title | Description |
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| OG000 | Bupropion XL | In a double-blind 8-week acute treatment phase, participants received 1 tablet of bupropion XL 150 milligram (mg) per day at dose level 1 (Week 0 to Week 1). At dose level 2 (Week 1 to Week 4), bupropion XL dose was increased to 300 mg per day (2 tablets of bupropion XL 150 mg) for further 3 weeks to ensure that participants had achieved the clinical recommended dose. At dose level 3 (Week 4 to Week 8), bupropion XL dose was still maintained at 300 mg per day (2 tablets of bupropion XL 150 mg). To ensure study blind, the participants were dosed with placebo matching escitalopram at each dose level. After treatment phase, participants entered in taper phase where dose in was down-titrated step by step to reduce the possible withdrawal symptoms. In taper phase, both dose level 2 and dose level 3 were down titrated to dose level 1 for 1 week before discontinuation. |
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| Secondary | Remission Rate Based on HAMD-17 Total Score | HAMD-17 is an extensively used tool to assess the severity of depression and symptom improvement during the treatment. The HAMD-17 adopted for this study consisted of 17 questions with multiple choice responses, each of which is numerically scored. The HAMD-17 total score is calculated by summing the individual response scores if there is no missing response. HAMD-17 has a total score in a range of 0 (not present) to 52 (severe). Values at Day 0, Week 0 was considered as Baseline value. Remission was defined as HAMD-17 total scores at end of acute treatment phase (Week 8) <=7. | | Posted | | Number | | Percentage of Participants | | Up to Week 8 | | | | ID | Title | Description |
|---|
| OG000 | Bupropion XL | In a double-blind 8-week acute treatment phase, participants received 1 tablet of bupropion XL 150 milligram (mg) per day at dose level 1 (Week 0 to Week 1). At dose level 2 (Week 1 to Week 4), bupropion XL dose was increased to 300 mg per day (2 tablets of bupropion XL 150 mg) for further 3 weeks to ensure that participants had achieved the clinical recommended dose. At dose level 3 (Week 4 to Week 8), bupropion XL dose was still maintained at 300 mg per day (2 tablets of bupropion XL 150 mg). To ensure study blind, the participants were dosed with placebo matching escitalopram at each dose level. After treatment phase, participants entered in taper phase where dose in was down-titrated step by step to reduce the possible withdrawal symptoms. In taper phase, both dose level 2 and dose level 3 were down titrated to dose level 1 for 1 week before discontinuation. | |
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| Secondary | Sustained Response Rate Based on HAMD-17 Total Score | HAMD-17 is an extensively used tool to assess the severity of depression and symptom improvement during the treatment. The HAMD-17 adopted for this study consisted of 17 questions with multiple choice responses, each of which is numerically scored. The HAMD-17 total score is calculated by summing the individual response scores if there is no missing response. HAMD-17 has a total score in a range of 0 (not present) to 52 (severe). Values at Day 0, Week 0 was considered as Baseline value. Sustained response was defined as response at end of acute treatment phase and an earlier visit and the decrease from Baseline in non-missing HAMD-17 total scores at all visits between these two visits by at least 40%. | | Posted | | Number | | Percentage of Participants | | Up to Week 8 | | | | ID | Title | Description |
|---|
| OG000 | Bupropion XL | In a double-blind 8-week acute treatment phase, participants received 1 tablet of bupropion XL 150 milligram (mg) per day at dose level 1 (Week 0 to Week 1). At dose level 2 (Week 1 to Week 4), bupropion XL dose was increased to 300 mg per day (2 tablets of bupropion XL 150 mg) for further 3 weeks to ensure that participants had achieved the clinical recommended dose. At dose level 3 (Week 4 to Week 8), bupropion XL dose was still maintained at 300 mg per day (2 tablets of bupropion XL 150 mg). To ensure study blind, the participants were dosed with placebo matching escitalopram at each dose level. After treatment phase, participants entered in taper phase where dose in was down-titrated step by step to reduce the possible withdrawal symptoms. In taper phase, both dose level 2 and dose level 3 were down titrated to dose level 1 for 1 week before discontinuation. |
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| Secondary | Sustained Remission Rate Based on HAMD-17 Total Score | HAMD-17 is an extensively used tool to assess the severity of depression and symptom improvement during the treatment. The HAMD-17 adopted for this study consisted of 17 questions with multiple choice responses, each of which is numerically scored. The HAMD-17 total score is calculated by summing the individual response scores if there is no missing response. HAMD-17 has a total score in a range of 0 (not present) to 52 (severe). Values at Day 0, Week 0 was considered as Baseline value. Sustained remission was defined as remission at end of acute treatment phase and an earlier visit and non-missing HAMD-17 total scores at all visits between these two visits <=8. | | Posted | | Number | | Percentage of Participants | | Up to Week 8 | | | | ID | Title | Description |
|---|
| OG000 | Bupropion XL | In a double-blind 8-week acute treatment phase, participants received 1 tablet of bupropion XL 150 milligram (mg) per day at dose level 1 (Week 0 to Week 1). At dose level 2 (Week 1 to Week 4), bupropion XL dose was increased to 300 mg per day (2 tablets of bupropion XL 150 mg) for further 3 weeks to ensure that participants had achieved the clinical recommended dose. At dose level 3 (Week 4 to Week 8), bupropion XL dose was still maintained at 300 mg per day (2 tablets of bupropion XL 150 mg). To ensure study blind, the participants were dosed with placebo matching escitalopram at each dose level. After treatment phase, participants entered in taper phase where dose in was down-titrated step by step to reduce the possible withdrawal symptoms. In taper phase, both dose level 2 and dose level 3 were down titrated to dose level 1 for 1 week before discontinuation. |
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| Secondary | Change From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score at Weeks 1, 2, 4, 6 and 8 | MADRS is a 10-point rating scale. Each item is scored on a scale of 0-6, with a total score range of 0-60. Higher score indicates worst symptoms. This scale is mainly used to assess the efficacy of antidepressant treatment. The ratings were based on the signs and symptoms during the preceding week prior to the visit. Values at Day0, Week 0 was considered as Baseline value. The observed MADRS total score was considered as missing if any item is missing. Change from Baseline in MADRS was obtained by subtracting the Baseline value from the specific post-Baseline value. All participants in the PP population were analyzed and n=X in the category titles represented the number of participants with data available at the specified time points. | | Posted | | Least Squares Mean | Standard Error | Scores on a scale | | Baseline (Week 0) and Weeks 1, 2, 4, 6 and 8 | | | | ID | Title | Description |
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| OG000 | Bupropion XL | In a double-blind 8-week acute treatment phase, participants received 1 tablet of bupropion XL 150 milligram (mg) per day at dose level 1 (Week 0 to Week 1). At dose level 2 (Week 1 to Week 4), bupropion XL dose was increased to 300 mg per day (2 tablets of bupropion XL 150 mg) for further 3 weeks to ensure that participants had achieved the clinical recommended dose. At dose level 3 (Week 4 to Week 8), bupropion XL dose was still maintained at 300 mg per day (2 tablets of bupropion XL 150 mg). To ensure study blind, the participants were dosed with placebo matching escitalopram at each dose level. After treatment phase, participants entered in taper phase where dose in was down-titrated step by step to reduce the possible withdrawal symptoms. In taper phase, both dose level 2 and dose level 3 were down titrated to dose level 1 for 1 week before discontinuation. |
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| Secondary | Change From Baseline in HAMD-17 Depressed Mood Subscale Score (Score of Item 1) at Weeks 1, 2, 4, 6 and 8 | HAMD-17 is an extensively used tool to assess the severity of depression and symptom improvement during the treatment. The HAMD-17 adopted for this study consisted of 17 questions with multiple choice responses, each of which is numerically scored. The HAMD-17 Depressed Mood Subscale is a factor score of item-1 (Depressed Mood) of HAMD-17 scale. This subscale has a score in a range of 0 (absence of depressed mood feelings) to 4 (when participants report virtually only these feeling states in his/her spontaneous verbal and non-verbal communicationtotal score). Values at Day 0, Week 0 was considered as Baseline value. Change from Baseline was calculated by subtracting the Baseline response from the specific post-Baseline response. All participants in the PP population were analyzed and n=X in the category titles represented the number of participants with data available at the specified time points. | | Posted | | Least Squares Mean | Standard Deviation | Scores on a scale | | Baseline (Week 0) and Weeks 1, 2, 4, 6 and 8 | | | | ID | Title | Description |
|---|
| OG000 | Bupropion XL | In a double-blind 8-week acute treatment phase, participants received 1 tablet of bupropion XL 150 milligram (mg) per day at dose level 1 (Week 0 to Week 1). At dose level 2 (Week 1 to Week 4), bupropion XL dose was increased to 300 mg per day (2 tablets of bupropion XL 150 mg) for further 3 weeks to ensure that participants had achieved the clinical recommended dose. At dose level 3 (Week 4 to Week 8), bupropion XL dose was still maintained at 300 mg per day (2 tablets of bupropion XL 150 mg). To ensure study blind, the participants were dosed with placebo matching escitalopram at each dose level. After treatment phase, participants entered in taper phase where dose in was down-titrated step by step to reduce the possible withdrawal symptoms. In taper phase, both dose level 2 and dose level 3 were down titrated to dose level 1 for 1 week before discontinuation. |
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| Secondary | Change From Baseline in HAMD-17 Anxiety/Somatization Subscale Score (Sum of Scores of Items 10, 11, 12, 13, 15 and 17) at Weeks 1, 2, 4, 6 and 8 | HAMD-17 is an extensively used tool to assess the severity of depression and symptom improvement during the treatment. The HAMD-17 adopted for this study consisted of 17 questions with multiple choice responses, each of which is numerically scored. The HAMD-17 Anxiety/Somatization subscale score was derived as sum of scores of items 10, 11, 12, 13, 15 and 17 from HAMD-17. This subscale has a score in a range of 0 (absence of condition) to 18 (most severe condition). Values at Day 0, Week 0 was considered as Baseline value. Change from Baseline was calculated by subtracting the Baseline response from the specific post-Baseline response. All participants in the PP population were analyzed and n=X in the category titles represented the number of participants with data available at the specified time points. | | Posted | | Least Squares Mean | Standard Error | Scores on a scale | | Baseline (Week 0) and Weeks 1, 2, 4, 6 and 8 | | | | ID | Title | Description |
|---|
| OG000 | Bupropion XL | In a double-blind 8-week acute treatment phase, participants received 1 tablet of bupropion XL 150 milligram (mg) per day at dose level 1 (Week 0 to Week 1). At dose level 2 (Week 1 to Week 4), bupropion XL dose was increased to 300 mg per day (2 tablets of bupropion XL 150 mg) for further 3 weeks to ensure that participants had achieved the clinical recommended dose. At dose level 3 (Week 4 to Week 8), bupropion XL dose was still maintained at 300 mg per day (2 tablets of bupropion XL 150 mg). To ensure study blind, the participants were dosed with placebo matching escitalopram at each dose level. After treatment phase, participants entered in taper phase where dose in was down-titrated step by step to reduce the possible withdrawal symptoms. In taper phase, both dose level 2 and dose level 3 were down titrated to dose level 1 for 1 week before discontinuation. |
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| Secondary | Change From Baseline in HAMD-17 Retardation Subscale Score (Sum of Scores of Items 1, 7, 8 and 14) at Weeks 1, 2, 4, 6 and 8 | HAMD-17 is an extensively used tool to assess the severity of depression and symptom improvement during the treatment. The HAMD-17 adopted for this study consisted of 17 questions with multiple choice responses, each of which is numerically scored. The HAMD-17 Retardation subscale score was derived as sum of scores of items 1, 7, 8 and 14 from HAMD-17. This subscale has a score in a range of 0 (absence of condition) to 14 (most severe condition). Values at Day 0, Week 0 was considered as Baseline value. Change from Baseline was calculated by subtracting the Baseline response from the specific post-Baseline response. All participants in the PP population were analyzed and n=X in the category titles represented the number of participants with data available at the specified time points. | | Posted | | Least Squares Mean | Standard Error | Scores on a scale | | Baseline (Week 0) and Weeks 1, 2, 4, 6 and 8 | | | | ID | Title | Description |
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| OG000 | Bupropion XL | In a double-blind 8-week acute treatment phase, participants received 1 tablet of bupropion XL 150 milligram (mg) per day at dose level 1 (Week 0 to Week 1). At dose level 2 (Week 1 to Week 4), bupropion XL dose was increased to 300 mg per day (2 tablets of bupropion XL 150 mg) for further 3 weeks to ensure that participants had achieved the clinical recommended dose. At dose level 3 (Week 4 to Week 8), bupropion XL dose was still maintained at 300 mg per day (2 tablets of bupropion XL 150 mg). To ensure study blind, the participants were dosed with placebo matching escitalopram at each dose level. After treatment phase, participants entered in taper phase where dose in was down-titrated step by step to reduce the possible withdrawal symptoms. In taper phase, both dose level 2 and dose level 3 were down titrated to dose level 1 for 1 week before discontinuation. |
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| Secondary | Change From Baseline in HAMD-17 Sleep Disorder Subscale Score (Sum of Scores of Items 4, 5 and 6) at Weeks 1, 2, 4, 6 and 8 | HAMD-17 is an extensively used tool to assess the severity of depression and symptom improvement during the treatment. The HAMD-17 adopted for this study consisted of 17 questions with multiple choice responses, each of which is numerically scored. The HAMD-17 Sleep Disorder subscale score was derived as sum of scores of items 4, 5 and 6 from HAMD-17. This subscale has a score in a range of 0 (absence of condition) to 6 (most severe condition). Values at Day 0, Week 0 was considered as Baseline value. Change from Baseline was calculated by subtracting the Baseline response from the specific post-Baseline response. All participants in the PP population were analyzed and n=X in the category titles represented the number of participants with data available at the specified time points. | | Posted | | Least Squares Mean | Standard Error | Scores on a scale | | Baseline (Week 0) and Weeks 1, 2, 4, 6 and 8 | | | | ID | Title | Description |
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| OG000 | Bupropion XL | In a double-blind 8-week acute treatment phase, participants received 1 tablet of bupropion XL 150 milligram (mg) per day at dose level 1 (Week 0 to Week 1). At dose level 2 (Week 1 to Week 4), bupropion XL dose was increased to 300 mg per day (2 tablets of bupropion XL 150 mg) for further 3 weeks to ensure that participants had achieved the clinical recommended dose. At dose level 3 (Week 4 to Week 8), bupropion XL dose was still maintained at 300 mg per day (2 tablets of bupropion XL 150 mg). To ensure study blind, the participants were dosed with placebo matching escitalopram at each dose level. After treatment phase, participants entered in taper phase where dose in was down-titrated step by step to reduce the possible withdrawal symptoms. In taper phase, both dose level 2 and dose level 3 were down titrated to dose level 1 for 1 week before discontinuation. |
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| Secondary | Change From Baseline in Clinical Global Impression-Severity of Illness Scale (CGI-S) Score at Weeks 1, 2, 4, 6 and 8 | CGI-S records the severity of illness at specific time points, with a range of responses from 1 (normal, not at all ill) to 7 (among the most extremely ill participants). Participants with zero values (0) representing "Not assessed" were excluded from analysis. Values at Day 0, Week 0 was considered as Baseline value. Change from Baseline was obtained by subtracting the Baseline value from the specific post-Baseline value. All participants in the PP population were analyzed and n=X in the category titles represented the number of participants with data available at the specified time points. | | Posted | | Least Squares Mean | Standard Error | Scores on a scale | | Baseline (Week 0) and Weeks 1, 2, 4, 6 and 8 | | | | ID | Title | Description |
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| OG000 | Bupropion XL | In a double-blind 8-week acute treatment phase, participants received 1 tablet of bupropion XL 150 milligram (mg) per day at dose level 1 (Week 0 to Week 1). At dose level 2 (Week 1 to Week 4), bupropion XL dose was increased to 300 mg per day (2 tablets of bupropion XL 150 mg) for further 3 weeks to ensure that participants had achieved the clinical recommended dose. At dose level 3 (Week 4 to Week 8), bupropion XL dose was still maintained at 300 mg per day (2 tablets of bupropion XL 150 mg). To ensure study blind, the participants were dosed with placebo matching escitalopram at each dose level. After treatment phase, participants entered in taper phase where dose in was down-titrated step by step to reduce the possible withdrawal symptoms. In taper phase, both dose level 2 and dose level 3 were down titrated to dose level 1 for 1 week before discontinuation. |
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| Secondary | Percentage of Participants With a Clinical Global Impression Global Improvement (CGI-I) Score of 1 ("Very Much Improved") or 2 ("Much Improved") at Weeks 1, 2, 4, 6 and 8 | For CGI-I rating, the raters indicated their assessment of the participant's total improvement or worsening compared to the participant's condition at the Baseline visit, whether or not the improvement or worsening was thought to be treatment related. Scores ranges from 0 to 7 where 0 represents "Not assessed", and the remaining values 1-7 represent "Very much improved" (1) to "Very much worse" (7). Participants with score 0 were excluded from analysis. All participants in the PP population were analyzed and n=X in the category titles represented the number of participants with data available at the specified time points. | | Posted | | Number | | Percentage of Participants | | Baseline (Week 0) and Weeks 1, 2, 4, 6 and 8 | | | | ID | Title | Description |
|---|
| OG000 | Bupropion XL | In a double-blind 8-week acute treatment phase, participants received 1 tablet of bupropion XL 150 milligram (mg) per day at dose level 1 (Week 0 to Week 1). At dose level 2 (Week 1 to Week 4), bupropion XL dose was increased to 300 mg per day (2 tablets of bupropion XL 150 mg) for further 3 weeks to ensure that participants had achieved the clinical recommended dose. At dose level 3 (Week 4 to Week 8), bupropion XL dose was still maintained at 300 mg per day (2 tablets of bupropion XL 150 mg). To ensure study blind, the participants were dosed with placebo matching escitalopram at each dose level. After treatment phase, participants entered in taper phase where dose in was down-titrated step by step to reduce the possible withdrawal symptoms. In taper phase, both dose level 2 and dose level 3 were down titrated to dose level 1 for 1 week before discontinuation. |
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| Secondary | Number of Participants With Any Non-serious Adverse Event (AE) and Any Serious AE (SAE) | An AE is any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Any untoward event resulting in death, life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, congenital anomaly/birth defect, any other situation according to medical or scientific judgment that may not be immediately life-threatening or result in death or hospitalization but may jeopardize the participant or may require medical or surgical intervention or all events of possible drug-induced liver injury with hyperbilirubinemia were categorized as SAE. Participants who received any of the study treatment and had any non-serious AE or SAE were considered for analysis. Safety Population comprised of all participants who took at least one dose of the study medication. | | Posted | | Count of Participants | | Participants | | Up to Week 10 | | | | ID | Title | Description |
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| OG000 | Bupropion XL | In a double-blind 8-week acute treatment phase, participants received 1 tablet of bupropion XL 150 milligram (mg) per day at dose level 1 (Week 0 to Week 1). At dose level 2 (Week 1 to Week 4), bupropion XL dose was increased to 300 mg per day (2 tablets of bupropion XL 150 mg) for further 3 weeks to ensure that participants had achieved the clinical recommended dose. At dose level 3 (Week 4 to Week 8), bupropion XL dose was still maintained at 300 mg per day (2 tablets of bupropion XL 150 mg). To ensure study blind, the participants were dosed with placebo matching escitalopram at each dose level. After treatment phase, participants entered in taper phase where dose in was down-titrated step by step to reduce the possible withdrawal symptoms. In taper phase, both dose level 2 and dose level 3 were down titrated to dose level 1 for 1 week before discontinuation. |
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| Secondary | Change From Baseline in Hemoglobin, Total Protein, Albumin and Mean Corpuscle Hemoglobin Concentration (MCHC) at the Indicated Time Points | Blood samples were collected at Screening (within 14 days prior to dosing) and at Week 8, Taper visit (Week 9) and Follow-up visit (Week 10). Baseline was considered as the value obtained at Screening. Change from Baseline was calculated by subtracting the Baseline value from the specific post-Baseline values. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles). | | Posted | | Mean | Standard Deviation | Gram per Liter (G/L) | | Up to Week 10 | | | | ID | Title | Description |
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| OG000 | Bupropion XL | In a double-blind 8-week acute treatment phase, participants received 1 tablet of bupropion XL 150 milligram (mg) per day at dose level 1 (Week 0 to Week 1). At dose level 2 (Week 1 to Week 4), bupropion XL dose was increased to 300 mg per day (2 tablets of bupropion XL 150 mg) for further 3 weeks to ensure that participants had achieved the clinical recommended dose. At dose level 3 (Week 4 to Week 8), bupropion XL dose was still maintained at 300 mg per day (2 tablets of bupropion XL 150 mg). To ensure study blind, the participants were dosed with placebo matching escitalopram at each dose level. After treatment phase, participants entered in taper phase where dose in was down-titrated step by step to reduce the possible withdrawal symptoms. In taper phase, both dose level 2 and dose level 3 were down titrated to dose level 1 for 1 week before discontinuation. | | OG001 |
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| Secondary | Change From Baseline in Hematocrit at the Indicated Time Points | Blood samples were collected at Screening (within 14 days prior to dosing) and at Week 8, Taper visit (Week 9) and Follow-up visit (Week 10). Baseline was considered as the value obtained at Screening. Change from Baseline was calculated by subtracting the Baseline value from the specific post-Baseline values. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles). | | Posted | | Mean | Standard Deviation | Proportion of red blood cells in blood | | Up to Week 10 | | | | ID | Title | Description |
|---|
| OG000 | Bupropion XL | In a double-blind 8-week acute treatment phase, participants received 1 tablet of bupropion XL 150 milligram (mg) per day at dose level 1 (Week 0 to Week 1). At dose level 2 (Week 1 to Week 4), bupropion XL dose was increased to 300 mg per day (2 tablets of bupropion XL 150 mg) for further 3 weeks to ensure that participants had achieved the clinical recommended dose. At dose level 3 (Week 4 to Week 8), bupropion XL dose was still maintained at 300 mg per day (2 tablets of bupropion XL 150 mg). To ensure study blind, the participants were dosed with placebo matching escitalopram at each dose level. After treatment phase, participants entered in taper phase where dose in was down-titrated step by step to reduce the possible withdrawal symptoms. In taper phase, both dose level 2 and dose level 3 were down titrated to dose level 1 for 1 week before discontinuation. | | OG001 | Escitalopram |
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| Secondary | Change From Baseline in White Blood Cell (WBC) Count, Total Neutrophil, Lymphocyte, Basophil, Eosinophil, Monocyte and Platelet Count at the Indicated Time Points | Blood samples were collected at Screening (within 14 days prior to dosing) and at Week 8, Taper visit (Week 9) and Follow-up visit (Week 10). Baseline was considered as the value obtained at Screening. Change from Baseline was calculated by subtracting the Baseline value from the specific post-Baseline values. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles). | | Posted | | Mean | Standard Deviation | Giga cells per liter (GI/L) | | Up to Week 10 | | | | ID | Title | Description |
|---|
| OG000 | Bupropion XL | In a double-blind 8-week acute treatment phase, participants received 1 tablet of bupropion XL 150 milligram (mg) per day at dose level 1 (Week 0 to Week 1). At dose level 2 (Week 1 to Week 4), bupropion XL dose was increased to 300 mg per day (2 tablets of bupropion XL 150 mg) for further 3 weeks to ensure that participants had achieved the clinical recommended dose. At dose level 3 (Week 4 to Week 8), bupropion XL dose was still maintained at 300 mg per day (2 tablets of bupropion XL 150 mg). To ensure study blind, the participants were dosed with placebo matching escitalopram at each dose level. After treatment phase, participants entered in taper phase where dose in was down-titrated step by step to reduce the possible withdrawal symptoms. In taper phase, both dose level 2 and dose level 3 were down titrated to dose level 1 for 1 week before discontinuation. | |
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| Secondary | Change From Baseline in Total Bilirubin, Direct Bilirubin and Creatinine at the Indicated Time Points | Blood samples were collected at Screening (within 14 days prior to dosing) and at Week 8, Taper visit (Week 9) and Follow-up visit (Week 10). Baseline was considered as the value obtained at Screening. Change from Baseline was calculated by subtracting the Baseline value from the specific post-Baseline values. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles). | | Posted | | Mean | Standard Deviation | Micromoles per liter (µmol/L) | | Up to Week 10 | | | | ID | Title | Description |
|---|
| OG000 | Bupropion XL | In a double-blind 8-week acute treatment phase, participants received 1 tablet of bupropion XL 150 milligram (mg) per day at dose level 1 (Week 0 to Week 1). At dose level 2 (Week 1 to Week 4), bupropion XL dose was increased to 300 mg per day (2 tablets of bupropion XL 150 mg) for further 3 weeks to ensure that participants had achieved the clinical recommended dose. At dose level 3 (Week 4 to Week 8), bupropion XL dose was still maintained at 300 mg per day (2 tablets of bupropion XL 150 mg). To ensure study blind, the participants were dosed with placebo matching escitalopram at each dose level. After treatment phase, participants entered in taper phase where dose in was down-titrated step by step to reduce the possible withdrawal symptoms. In taper phase, both dose level 2 and dose level 3 were down titrated to dose level 1 for 1 week before discontinuation. | | OG001 |
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| Secondary | Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma-glutamyl Transpeptidase (GGT) and Lactose Dehydrogenase (LD) at the Indicated Time Points | Blood samples were collected at Screening (within 14 days prior to dosing) and at Week 8, Taper visit (Week 9) and Follow-up visit (Week 10). Baseline was considered as the value obtained at Screening. Change from Baseline was calculated by subtracting the Baseline value from the specific post-Baseline values. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles). | | Posted | | Mean | Standard Deviation | International Units per liter (IU/L) | | Up to Week 10 | | | | ID | Title | Description |
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| OG000 | Bupropion XL | In a double-blind 8-week acute treatment phase, participants received 1 tablet of bupropion XL 150 milligram (mg) per day at dose level 1 (Week 0 to Week 1). At dose level 2 (Week 1 to Week 4), bupropion XL dose was increased to 300 mg per day (2 tablets of bupropion XL 150 mg) for further 3 weeks to ensure that participants had achieved the clinical recommended dose. At dose level 3 (Week 4 to Week 8), bupropion XL dose was still maintained at 300 mg per day (2 tablets of bupropion XL 150 mg). To ensure study blind, the participants were dosed with placebo matching escitalopram at each dose level. After treatment phase, participants entered in taper phase where dose in was down-titrated step by step to reduce the possible withdrawal symptoms. In taper phase, both dose level 2 and dose level 3 were down titrated to dose level 1 for 1 week before discontinuation. |
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| Secondary | Change From Baseline in Calcium, Chloride, Cholesterol, Glucose, Potassium, Sodium, Triglyceride and Urea at the Indicated Time Points | Blood samples were collected at Screening (within 14 days prior to dosing) and at Week 8, Taper visit (Week 9) and Follow-up visit (Week 10). Baseline was considered as the value obtained at Screening. Change from Baseline was calculated by subtracting the Baseline value from the specific post-Baseline values. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles). | | Posted | | Mean | Standard Deviation | Millimole per liter (mmol/L) | | Up to Week 10 | | | | ID | Title | Description |
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| OG000 | Bupropion XL | In a double-blind 8-week acute treatment phase, participants received 1 tablet of bupropion XL 150 milligram (mg) per day at dose level 1 (Week 0 to Week 1). At dose level 2 (Week 1 to Week 4), bupropion XL dose was increased to 300 mg per day (2 tablets of bupropion XL 150 mg) for further 3 weeks to ensure that participants had achieved the clinical recommended dose. At dose level 3 (Week 4 to Week 8), bupropion XL dose was still maintained at 300 mg per day (2 tablets of bupropion XL 150 mg). To ensure study blind, the participants were dosed with placebo matching escitalopram at each dose level. After treatment phase, participants entered in taper phase where dose in was down-titrated step by step to reduce the possible withdrawal symptoms. In taper phase, both dose level 2 and dose level 3 were down titrated to dose level 1 for 1 week before discontinuation. | | OG001 |
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| Secondary | Change From Baseline in Mean Corpuscle Hemoglobin (MCH) at the Indicated Time Points | Blood samples were collected at Screening (within 14 days prior to dosing) and at Week 8, Taper visit (Week 9) and Follow-up visit (Week 10). Baseline was considered as the value obtained at Screening. Change from Baseline was calculated by subtracting the Baseline value from the specific post-Baseline values. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles). | | Posted | | Mean | Standard Deviation | Picograms | | Up to Week 10 | | | | ID | Title | Description |
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| OG000 | Bupropion XL | In a double-blind 8-week acute treatment phase, participants received 1 tablet of bupropion XL 150 milligram (mg) per day at dose level 1 (Week 0 to Week 1). At dose level 2 (Week 1 to Week 4), bupropion XL dose was increased to 300 mg per day (2 tablets of bupropion XL 150 mg) for further 3 weeks to ensure that participants had achieved the clinical recommended dose. At dose level 3 (Week 4 to Week 8), bupropion XL dose was still maintained at 300 mg per day (2 tablets of bupropion XL 150 mg). To ensure study blind, the participants were dosed with placebo matching escitalopram at each dose level. After treatment phase, participants entered in taper phase where dose in was down-titrated step by step to reduce the possible withdrawal symptoms. In taper phase, both dose level 2 and dose level 3 were down titrated to dose level 1 for 1 week before discontinuation. | | OG001 | Escitalopram |
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| Secondary | Change From Baseline in Mean Corpuscle Volume (MCV) at the Indicated Time Points | Blood samples were collected at Screening (within 14 days prior to dosing) and at Week 8, Taper visit (Week 9) and Follow-up visit (Week 10). Baseline was considered as the value obtained at Screening. Change from Baseline was calculated by subtracting the Baseline value from the specific post-Baseline values. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles). | | Posted | | Mean | Standard Deviation | Femtoliter | | Up to Week 10 | | | | ID | Title | Description |
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| OG000 | Bupropion XL | In a double-blind 8-week acute treatment phase, participants received 1 tablet of bupropion XL 150 milligram (mg) per day at dose level 1 (Week 0 to Week 1). At dose level 2 (Week 1 to Week 4), bupropion XL dose was increased to 300 mg per day (2 tablets of bupropion XL 150 mg) for further 3 weeks to ensure that participants had achieved the clinical recommended dose. At dose level 3 (Week 4 to Week 8), bupropion XL dose was still maintained at 300 mg per day (2 tablets of bupropion XL 150 mg). To ensure study blind, the participants were dosed with placebo matching escitalopram at each dose level. After treatment phase, participants entered in taper phase where dose in was down-titrated step by step to reduce the possible withdrawal symptoms. In taper phase, both dose level 2 and dose level 3 were down titrated to dose level 1 for 1 week before discontinuation. | | OG001 | Escitalopram |
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| Secondary | Change From Baseline in Red Blood Cell (RBC) Count at the Indicated Time Points | Blood samples were collected at Screening (within 14 days prior to dosing) and at Week 8, Taper visit (Week 9) and Follow-up visit (Week 10). Baseline was considered as the value obtained at Screening. Change from Baseline was calculated by subtracting the Baseline value from the specific post-Baseline values. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles). | | Posted | | Mean | Standard Deviation | 10^12 cells per liter | | Up to Week 10 | | | | ID | Title | Description |
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| OG000 | Bupropion XL | In a double-blind 8-week acute treatment phase, participants received 1 tablet of bupropion XL 150 milligram (mg) per day at dose level 1 (Week 0 to Week 1). At dose level 2 (Week 1 to Week 4), bupropion XL dose was increased to 300 mg per day (2 tablets of bupropion XL 150 mg) for further 3 weeks to ensure that participants had achieved the clinical recommended dose. At dose level 3 (Week 4 to Week 8), bupropion XL dose was still maintained at 300 mg per day (2 tablets of bupropion XL 150 mg). To ensure study blind, the participants were dosed with placebo matching escitalopram at each dose level. After treatment phase, participants entered in taper phase where dose in was down-titrated step by step to reduce the possible withdrawal symptoms. In taper phase, both dose level 2 and dose level 3 were down titrated to dose level 1 for 1 week before discontinuation. | | OG001 | Escitalopram |
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| Secondary | Number of Participants With Urinalysis Data Outside the Normal Range | Urine samples were collected at Screening (within 14 days prior to dosing) and at Week 8, Taper visit (Week 9) and Follow-up visit (Week 10). Number of participants with urine specific gravity and potential of hydrogen (pH) outside (higher or lower) the normal range are presented. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles). | | Posted | | Number | | Participants | | Up to Week 10 | | | | ID | Title | Description |
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| OG000 | Bupropion XL | In a double-blind 8-week acute treatment phase, participants received 1 tablet of bupropion XL 150 milligram (mg) per day at dose level 1 (Week 0 to Week 1). At dose level 2 (Week 1 to Week 4), bupropion XL dose was increased to 300 mg per day (2 tablets of bupropion XL 150 mg) for further 3 weeks to ensure that participants had achieved the clinical recommended dose. At dose level 3 (Week 4 to Week 8), bupropion XL dose was still maintained at 300 mg per day (2 tablets of bupropion XL 150 mg). To ensure study blind, the participants were dosed with placebo matching escitalopram at each dose level. After treatment phase, participants entered in taper phase where dose in was down-titrated step by step to reduce the possible withdrawal symptoms. In taper phase, both dose level 2 and dose level 3 were down titrated to dose level 1 for 1 week before discontinuation. | | OG001 | Escitalopram | |
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| Secondary | Number of Participants With Vital Sign Parameters Outside the Clinical Concern Range | Vital signs including systolic blood pressure (SBP), diastolic blood pressure (DBP) and heart rate (HR) were taken at Screening (within 14 days prior to dosing), randomization visit (Week 0) and at Weeks 1, 2, 4, 6, 8, Taper visit (Week 9) and Follow-up visit (Week 10). SBP <30 or >170 millimeter of mercury (mmHg); DBP <20 or >110 mmHg and heart rate <40 or >120 beats per minute (bpm) were considered as values outside of clinical concern range and were presented as 'High' or 'Low' values. Number of participants with vital signs outside of clinical concern range at any post-Baseline visit are presented. Only those participants with data available at the specified time points were analyzed. | | Posted | | Number | | Participants | | Up to Week 10 | | | | ID | Title | Description |
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| OG000 | Bupropion XL | In a double-blind 8-week acute treatment phase, participants received 1 tablet of bupropion XL 150 milligram (mg) per day at dose level 1 (Week 0 to Week 1). At dose level 2 (Week 1 to Week 4), bupropion XL dose was increased to 300 mg per day (2 tablets of bupropion XL 150 mg) for further 3 weeks to ensure that participants had achieved the clinical recommended dose. At dose level 3 (Week 4 to Week 8), bupropion XL dose was still maintained at 300 mg per day (2 tablets of bupropion XL 150 mg). To ensure study blind, the participants were dosed with placebo matching escitalopram at each dose level. After treatment phase, participants entered in taper phase where dose in was down-titrated step by step to reduce the possible withdrawal symptoms. In taper phase, both dose level 2 and dose level 3 were down titrated to dose level 1 for 1 week before discontinuation. |
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| Secondary | Number of Participants With Electrocardiogram (ECG) Data Outside the Clinical Concern Range | ECG was recorded at Screening (within 14 days prior to dosing) and at Week 8, Taper visit (Week 9) and Follow-up visit (Week 10). PR interval <110 or >220 millisecond (msec); QRS interval <60 or >120 msec and corrected QT (QTc) interval >450 msec were considered as values outside of clinical concern range and were presented as 'High' or 'Low' values. Number of participants with ECG data outside of clinical concern range at any post-Baseline visit are presented. Only those participants with data available at the specified time points were analyzed. | | Posted | | Number | | Participants | | Up to Week 10 | | | | ID | Title | Description |
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| OG000 | Bupropion XL | In a double-blind 8-week acute treatment phase, participants received 1 tablet of bupropion XL 150 milligram (mg) per day at dose level 1 (Week 0 to Week 1). At dose level 2 (Week 1 to Week 4), bupropion XL dose was increased to 300 mg per day (2 tablets of bupropion XL 150 mg) for further 3 weeks to ensure that participants had achieved the clinical recommended dose. At dose level 3 (Week 4 to Week 8), bupropion XL dose was still maintained at 300 mg per day (2 tablets of bupropion XL 150 mg). To ensure study blind, the participants were dosed with placebo matching escitalopram at each dose level. After treatment phase, participants entered in taper phase where dose in was down-titrated step by step to reduce the possible withdrawal symptoms. In taper phase, both dose level 2 and dose level 3 were down titrated to dose level 1 for 1 week before discontinuation. | |
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| Secondary | Change From Baseline in Changes in Sexual Function Questionnaire (CSFQ) | CSFQ is a questionnaire about sexual activity and sexual function (sexual intercourse, masturbation, sexual fantasies and other activity). CSFQ is a gender-specific questionnaire. Both male and female versions consist of 14 items, each with 5 possible answers. CSFQ has a score in a range of 14 to 70. Higher score indicates higher sexual activity and sexual function. Value at Day 0 (Week 0) was considered as Baseline value. Change from Baseline at Week 8 was calculated by subtracting the Baseline score from the specific post-Baseline score. Only those participants with data available at the specified time points were analyzed. | | Posted | | Mean | Standard Deviation | Scores on a scale | | Baseline (Day 0) and Week 8 | | | | ID | Title | Description |
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| OG000 | Bupropion XL | In a double-blind 8-week acute treatment phase, participants received 1 tablet of bupropion XL 150 milligram (mg) per day at dose level 1 (Week 0 to Week 1). At dose level 2 (Week 1 to Week 4), bupropion XL dose was increased to 300 mg per day (2 tablets of bupropion XL 150 mg) for further 3 weeks to ensure that participants had achieved the clinical recommended dose. At dose level 3 (Week 4 to Week 8), bupropion XL dose was still maintained at 300 mg per day (2 tablets of bupropion XL 150 mg). To ensure study blind, the participants were dosed with placebo matching escitalopram at each dose level. After treatment phase, participants entered in taper phase where dose in was down-titrated step by step to reduce the possible withdrawal symptoms. In taper phase, both dose level 2 and dose level 3 were down titrated to dose level 1 for 1 week before discontinuation. |
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| Secondary | Number of Participants With Suicidal Ideation or Behavior During Treatment Assessed by Columbia Suicide Severity Rating Scale (C-SSRS) | C-SSRS is an assessment tool that evaluates suicidal ideation and behavior. It consists of 10 items, each with two possible answers (yes/no). Suicidal ideation was interpreted if "yes" answer at any time during treatment to any one of the five suicidal ideation questions (item 1-5) on the C-SSRS. Suicidal behavior was interpreted if a "yes" answer at any time during treatment to any one of the five suicidal behavior questions (item 6-10) on the C-SSRS. Suicidal ideation or behavior is interpreted if a "yes" answer at any time during treatment to any one of the ten suicidal ideation and behavior questions (item 1-10) on the C-SSRS. Number of participants with at least one on-treatment C-SSRS assessment were analyzed. Only those participants with data available at the specified time points were analyzed. | | Posted | | Number | | Participants | | Baseline and up to Taper visit (Week 9) | | | | ID | Title | Description |
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| OG000 | Bupropion XL | In a double-blind 8-week acute treatment phase, participants received 1 tablet of bupropion XL 150 milligram (mg) per day at dose level 1 (Week 0 to Week 1). At dose level 2 (Week 1 to Week 4), bupropion XL dose was increased to 300 mg per day (2 tablets of bupropion XL 150 mg) for further 3 weeks to ensure that participants had achieved the clinical recommended dose. At dose level 3 (Week 4 to Week 8), bupropion XL dose was still maintained at 300 mg per day (2 tablets of bupropion XL 150 mg). To ensure study blind, the participants were dosed with placebo matching escitalopram at each dose level. After treatment phase, participants entered in taper phase where dose in was down-titrated step by step to reduce the possible withdrawal symptoms. In taper phase, both dose level 2 and dose level 3 were down titrated to dose level 1 for 1 week before discontinuation. |
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