| Primary | Average Change of the MADRS (Montgomery-Asberg Depression Rating Scale) Total Score From Baseline to Final Visit After 12 Weeks of Treatment | Montgomery-Asberg Depression Rating Scale (MADRS)is a 10 item questionaire preformed during a clinical interview asking broad to detailed questions about symptoms which allows a precise rating of severity of symptoms of the past week. Questions are scored 0-6. Total Score 0-60, the higher the score indicates the most severely depressed patients. | Modified Intent to Treat (mITT): All treated patients with MADRS score at baseline and post baseline (i.e., at visit 4 and/or 5). The High/Low scores for this population were 32/11. | Posted | | Mean | Standard Deviation | Score on a Scale | | Baseline and Week 12 | | | | ID | Title | Description |
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| OG000 | Ropinirole | Subjects who were treated on day 1-2 with 0.25 mg/day of ropinirole and on days 3-7 0.5 mg for 12 weeks if tolerated. After two weeks, dose could be increased weekly by 0.5mg a day up to 4 mg maximum dose. | | OG001 | Placebo | Subjects who took no investigational product. |
| | | Title | Denominators | Categories |
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| | | Title | Measurements |
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| - OG000-10.1± 7.3
- OG001-6.5± 7.6
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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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| | ANCOVA | | <0.001 | | Mean Difference (Final Values) | -3.6 | | | | 95 | -5.6 | -1.6 | | | Mean difference = Ropinirole minus Placebo. Used adjusted change from baseline. | No | Superiority or Other | | |
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| Secondary | Average Change of the MADRS (Montgomery-Asberg Depression Rating Scale) Total Score From Baseline to Final Visit After 12 Weeks of Treatment in Participants With Signs of at Least Moderate Depression (MADRS Score: >=18) | Montgomery-Asberg Depression Rating Scale (MADRS)is a 10 item questionaire preformed during a clinical interview asking broad to detailed questions about symptoms which allows a precise rating of severity of symptoms of the past week. Questions are scored 0-6. Total Score 0-60, the higher the score indicates the most severely depressed patients. | Modified Intent to Treat (mITT): All treated patients with MADRS score at baseline and post baseline (i.e., at visit 4 and/or 5). Sub-population with MADRS scores>=18: Ropinirole 91 and Placebo 29. The high/Low scores for the mITT population were 32/11. | Posted | | Mean | Standard Deviation | Score on a Scale | | Baseline and Week 12 | | | | ID | Title | Description |
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| OG000 | Ropinirole | Subjects who were treated on day 1-2 with 0.25 mg/day of ropinirole and on days 3-7 0.5 mg for 12 weeks if tolerated. After two weeks, dose could be increased weekly by 0.5mg a day up to 4 mg maximum dose. | | OG001 | Placebo | Subjects who took no investigational product. |
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| Secondary | Average Change of the HAM-D (Hamilton Depression Rating Scale, 17-item-Version) Total Score From Baseline to Final Visit After 12 Weeks of Treatment | 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 HAMD score range from 0 (not ill) to 54 (severely ill). | Modified Intent to Treat (mITT): All treated patients with MADRS score at baseline and post baseline (i.e., at visit 4 and/or 5). The High/Low HAM-D scores for this population were 27/5. | Posted | | Mean | Standard Deviation | Score on a Scale | | Baseline and Week 12 | | | | ID | Title | Description |
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| OG000 | Ropinirole | Subjects who were treated on day 1-2 with 0.25 mg/day of ropinirole and on days 3-7 0.5 mg for 12 weeks if tolerated. After two weeks, dose could be increased weekly by 0.5mg a day up to 4 mg maximum dose. | | OG001 | Placebo | Subjects who took no investigational product. |
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| Secondary | Average Change of the HAM-D Total Score From Baseline to Final Visit After 12 Weeks of Treatment in Participants With Signs of an at Least Moderate Depression (HAM-D Score >= 15) at Baseline | 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 HAMD score range from 0 (not ill) to 54(severely ill). | Modified Intent to Treat (mITT): All treated patients with MADRS score at baseline and post baseline (i.e., at visit 4 and/or 5). Sub-population with HAM-D scores>=15: Ropinirole 93 and Placebo 33 | Posted | | Mean | Standard Deviation | Score on a Scale | | Baseline and Week 12 | | | | ID | Title | Description |
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| OG000 | Ropinirole | Subjects who were treated on day 1-2 with 0.25 mg/day of ropinirole and on days 3-7 0.5 mg for 12 weeks if tolerated. After two weeks, dose could be increased weekly by 0.5mg a day up to 4 mg maximum dose. | | OG001 | Placebo | Subjects who took no investigational product. |
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| Secondary | Average Change of the Beck Depression Inventory (BDI) Total Score From Baseline to Final Visit After 12 Weeks of Treatment | Becks Depression Inventory (BDI) is a 21 item self inventory evaluating symptoms of depression, cognition, and physical symptoms of fatigue, weight loss, and lack of interest in sex. The Higher the score represents most severely depressed participants. Score range for each items is 0-3 and Total score 0-63. | Modified Intent to Treat (mITT): All treated patients with MADRS score at baseline and post baseline (i.e., at visit 4 and/or 5). High/Low BDI scores for this population were 46/2. | Posted | | Mean | Standard Deviation | Score on a Scale | | Baseline and Week 12 | | | | ID | Title | Description |
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| OG000 | Ropinirole | Subjects who were treated on day 1-2 with 0.25 mg/day of ropinirole and on days 3-7 0.5 mg for 12 weeks if tolerated. After two weeks, dose could be increased weekly by 0.5mg a day up to 4 mg maximum dose. | | OG001 | Placebo | Subjects who took no investigational product. |
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| Secondary | Average Change of the Beck Depression Inventory (BDI) Total Score From Baseline to Final Visit After 12 Weeks of Treatment in Participants With Signs of an at Least Mild-moderate Depression (BDI >= 21) at Baseline | Becks Depression Inventory (BDI) is a 21 item self inventory evaluating symptoms of depression, cognition, and physical symptoms of fatigue, weight loss, and lack of interest in sex. The Higher the score represents most severely depressed participants. Score range for each items is 0-3 and total score 0-63. | Modified Intent to Treat (mITT): All treated patients with MADRS score at baseline and post baseline (i.e., at visit 4 and/or 5). Sub-population with BDI scores>=21: Ropinirole 75 and Placebo 28. High/Low BDI scores for this population were 46/2. | Posted | | Mean | Standard Deviation | Score on a Scale | | Baseline and Week 12 | | | | ID | Title | Description |
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| OG000 | Ropinirole | Subjects who were treated on day 1-2 with 0.25 mg/day of ropinirole and on days 3-7 0.5 mg for 12 weeks if tolerated. After two weeks, dose could be increased weekly by 0.5mg a day up to 4 mg maximum dose. | | OG001 | Placebo | Subjects who took no investigational product. |
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| Secondary | Percentage of Participants With at Least Moderate Depression (MADRS Score >= 18) at Baseline and in Week 12 | Montgomery-Asberg Depression Rating Scale (MADRS)is a 10 item questionaire preformed during a clinical interview asking broad to detailed questions about symptoms which allows a precise rating of severity of symptoms of the past week. Questions are scored 0-6. Total Score 0-60, the higher the score indicates the most severely depressed patients. | Modified Intent to Treat (mITT): All treated patients with MADRS score at baseline and post baseline (i.e., at week 12). | Posted | | Number | | Percentage of Participants | | Baseline and Week 12 | | | | ID | Title | Description |
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| OG000 | Ropinirole | Subjects who were treated on day 1-2 with 0.25 mg/day of ropinirole and on days 3-7 0.5 mg for 12 weeks if tolerated. After two weeks, dose could be increased weekly by 0.5mg a day up to 4 mg maximum dose. | | OG001 | Placebo | Subjects who took no investigational product. |
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| Secondary | Percentage of Participants With at Least Moderate Depression (HAM-D >= 15) at Baseline and in 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 HAMD score range from 0 (not ill) to 54 (severely ill). | Modified Intent to Treat (mITT): All treated patients with MADRS score at baseline and post baseline (i.e., at visit 4 and/or 5). Sub-population with HAM-D scores>=15. | Posted | | Number | | Percentage of Participants | | Baseline and Week 12 | | | | ID | Title | Description |
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| OG000 | Ropinirole | Subjects who were treated on day 1-2 with 0.25 mg/day of ropinirole and on days 3-7 0.5 mg for 12 weeks if tolerated. After two weeks, dose could be increased weekly by 0.5mg a day up to 4 mg maximum dose. | | OG001 | Placebo | Subjects who took no investigational product. |
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| Secondary | Percentage of Participants ("Responder") With a Decrease of MADRS Total Score of at Least 6 Points After 12 Weeks Compared to Baseline | Montgomery-Asberg Depression Rating Scale (MADRS)is a 10 item questionaire preformed during a clinical interview asking broad to detailed questions about symptoms which allows a precise rating of severity of symptoms of the past week. Questions are scored 0-6. Total Score 0-60, the higher the score indicates the most severely depressed patients. | Modified Intent to Treat (mITT): All treated patients with MADRS score at baseline and post baseline (i.e., at visit 4 and/or 5). | Posted | | Number | | Percentage of Participants | | Baseline and Week 12 | | | | ID | Title | Description |
|---|
| OG000 | Ropinirole | Subjects who were treated on day 1-2 with 0.25 mg/day of ropinirole and on days 3-7 0.5 mg for 12 weeks if tolerated. After two weeks, dose could be increased weekly by 0.5mg a day up to 4 mg maximum dose. | | OG001 | Placebo | Subjects who took no investigational product. |
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| Secondary | Percentage of Participants ("Responder") With a Decrease of MADRS Total Score of at Least 6 Points After 12 Weeks Compared to Baseline in Subjects With Signs of at Least Moderate Depression at Baseline (MADRS Score >= 18) | Montgomery-Asberg Depression Rating Scale (MADRS)is a 10 item questionaire preformed during a clinical interview asking broad to detailed questions about symptoms which allows a precise rating of severity of symptoms of the past week. Questions are scored 0-6. Total Score 0-60, the higher the score indicates the most severely depressed patients. | Modified Intent to Treat (mITT): All treated patients with MADRS score at baseline and post baseline (i.e., at visit 4 and/or 5). Sub-population with MADRS scores>=18: Ropinirole 91 and Placebo 29 | Posted | | Number | | Percentage of Participants | | Baseline and Week 12 | | | | ID | Title | Description |
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| OG000 | Ropinirole | Subjects who were treated on day 1-2 with 0.25 mg/day of ropinirole and on days 3-7 0.5 mg for 12 weeks if tolerated. After two weeks, dose could be increased weekly by 0.5mg a day up to 4 mg maximum dose. | | OG001 | Placebo | Subjects who took no investigational product. |
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| Secondary | Change in Average MADRS Score From Baseline to Final Visit (Week 12) in Participants With Major Depressive Episodes (Diagnosed by MINI Interview Modules A, B and C / DSM Criteria) | Montgomery-Asberg Depression Rating Scale (MADRS)is a 10 item questionaire preformed during a clinical interview asking broad to detailed questions about symptoms which allows a precise rating of severity of symptoms of the past week. Questions are scored 0-6. Total Score 0-60, the higher the score indicates the most severely depressed patients. | Modified Intent to Treat (mITT): All treated patients with MADRS score at baseline and post baseline (i.e., at visit 4 and/or 5). Sub-population diagnosed by MINI interview with Major Depressive Episodes: Ropinirole 93 and Placebo 34 | Posted | | Mean | Standard Deviation | Score on a Scale | | Baseline and Week 12 | | | | ID | Title | Description |
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| OG000 | Ropinirole | Subjects who were treated on day 1-2 with 0.25 mg/day of ropinirole and on days 3-7 0.5 mg for 12 weeks if tolerated. After two weeks, dose could be increased weekly by 0.5mg a day up to 4 mg maximum dose. | | OG001 | Placebo | Subjects who took no investigational product. |
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| Secondary | Change in Average HAM-D Score From Baseline to Final Visit (Week 12) in Participants With Major Depressive Episodes (Diagnosed by MINI Interview Modules A, B and C / DSM Criteria) | 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 HAMD score range from 0 (not ill) to 54 (severely ill). | Modified Intent to Treat (mITT): All treated patients with MADRS score at baseline and post baseline (i.e., at visit 4 and/or 5). Sub-population diagnosed by MINI interview with Major Depressive Episodes: Ropinirole 90 and Placebo 31. | Posted | | Mean | Standard Deviation | Score on a Scale | | Baseline and Week 12 | | | | ID | Title | Description |
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| OG000 | Ropinirole | Subjects who were treated on day 1-2 with 0.25 mg/day of ropinirole and on days 3-7 0.5 mg for 12 weeks if tolerated. After two weeks, dose could be increased weekly by 0.5mg a day up to 4 mg maximum dose. | | OG001 | Placebo | Subjects who took no investigational product. |
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| Secondary | Change in Average BDI Score From Baseline to Final Visit (Week 12) in Participants With Major Depressive Episodes (Diagnosed by MINI Interview Modules A, B and C / DSM Criteria) | Becks Depression Inventory (BDI) is a 21 item self inventory evaluating symptoms of depression, cognition, and physical symptoms of fatigue, weight loss, and lack of interest in sex. The Higher the score represents most severely depressed participants. Score range for each items is 0-3 and Total score 0-63. | Modified Intent to Treat (mITT): All treated patients with MADRS score at baseline and post baseline (i.e., at visit 4 and/or 5). Sub-population diagnosed by MINI interview with Major Depressive Episodes: Ropinirole 91 and Placebo 34. High/Low BDI scores for this population were 46/2. | Posted | | Mean | Standard Deviation | Score on a Scale | | Baseline and Week 12 | | | | ID | Title | Description |
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| OG000 | Ropinirole | Subjects who were treated on day 1-2 with 0.25 mg/day of ropinirole and on days 3-7 0.5 mg for 12 weeks if tolerated. After two weeks, dose could be increased weekly by 0.5mg a day up to 4 mg maximum dose. | | OG001 | Placebo | Subjects who took no investigational product. |
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| Secondary | Change in Average International Restless Legs Scale for Severity (IRLS) Scores in All Participants From Baseline to After 1, 4, and 12 Weeks | International Restless Legs Scale for Severity (IRLS)is a series of 10 questions which rate severity from 0-4 points for various questions and total score ranks: Very severe=31-40 points, Severe=21-30 points, Moderate=11-20 points, and Mild=1-10 points, None=0 points | Intent to Treat (ITT): All patients of the safety population with any psychometric data at baseline (within a single questionnaire) | Posted | | Mean | Standard Deviation | Score on a Scale | | Baseline, Week 1, Week 4, Week 12 | | | | ID | Title | Description |
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| OG000 | Ropinirole | Subjects who were treated on day 1-2 with 0.25 mg/day of ropinirole and on days 3-7 0.5 mg for 12 weeks if tolerated. After two weeks, dose could be increased weekly by 0.5mg a day up to 4 mg maximum dose. | | OG001 | Placebo | Subjects who took no investigational product. |
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| Secondary | Percentage of Participants With a Decrease of International Restless Legs Scale (IRLS) Scores of at Least 6 Points After 1, 4 and 12 Weeks | International Restless Legs Scale for Severity (IRLS)is a series of 10 questions which rate severity from 0-4 points for various questions and total score ranks: Very severe=31-40 points, Severe=21-30 points, Moderate=11-20 points, and Mild=1-10 points, None=0 points | Intent to Treat (ITT): All patients of the safety population with any psychometric data at baseline (within a single questionnaire) | Posted | | Number | | Percentage of Participants | | Week 1, Week 4, Week 12 | | | | ID | Title | Description |
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| OG000 | Ropinirole | Subjects who were treated on day 1-2 with 0.25 mg/day of ropinirole and on days 3-7 0.5 mg for 12 weeks if tolerated. After two weeks, dose could be increased weekly by 0.5mg a day up to 4 mg maximum dose. | | OG001 | Placebo | Subjects who took no investigational product. |
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| Secondary | Percentage of Participants With "Much Improved" or "Very Much Improved" on the Clinical Global Impression-Global Improvement Scale After 1, 4 and 12 Weeks | 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 range: 1-very much improved, 2-much improved, 3-minimally improved, 4-no change, 5- minimally worse, 6-much worse, to 7-very much worse. | Intent to Treat (ITT): All patients of the safety population with any psychometric data at baseline (within a single questionnaire) | Posted | | Number | | Percentage of Participants | | Week 1, Week 4, Week 12 | | | | ID | Title | Description |
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| OG000 | Ropinirole | Subjects who were treated on day 1-2 with 0.25 mg/day of ropinirole and on days 3-7 0.5 mg for 12 weeks if tolerated. After two weeks, dose could be increased weekly by 0.5mg a day up to 4 mg maximum dose. | | OG001 | Placebo | Subjects who took no investigational product. |
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| Secondary | Change From Average Baseline Score of Subscale of "Somnolence" in the Medical Outcomes Study Sleep Scale (MOS-SS) to Final Visit After 12 Weeks | Medical Outcome Study Sleep Scale (MOS-SS)-is a 12 item questionaire assessing sleep disturbance, sleep adequacy, somnolence, quantity of sleep, snoring, and awakening short of breath or with a headache. 10 question score from 1-6, 1 question scores 1-5 and 1 question asks average number of hours sleep each night. | Intent to Treat (ITT): All patients of the safety population with any psychometric data at baseline (within a single questionnaire) | Posted | | Mean | Standard Deviation | Score on a Scale | | Baseline and after Week 12 | | | | ID | Title | Description |
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| OG000 | Ropinirole | Subjects who were treated on day 1-2 with 0.25 mg/day of ropinirole and on days 3-7 0.5 mg for 12 weeks if tolerated. After two weeks, dose could be increased weekly by 0.5mg a day up to 4 mg maximum dose. | | OG001 | Placebo | Subjects who took no investigational product. |
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| Secondary | Change From Average Baseline Scores of Subscale "Sleep Disturbance" of the Medical Outcomes Study Sleep Scale (MOS-SS) to Final Visit After 12 Weeks | Medical Outcome Study Sleep Scale (MOS-SS)-is a 12 item questionaire assessing sleep disturbance, sleep adequacy, somnolence, quantity of sleep, snoring, and awakening short of breath or with a headache. 10 question score from 1-6, 1 question scores 1-5 and 1 question asks average number of hours sleep each night. | Intent to Treat (ITT): All patients of the safety population with any psychometric data at baseline (within a single questionnaire) | Posted | | Mean | Standard Deviation | Score on a Scale | | Baseline and after Week 12 | | | | ID | Title | Description |
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| OG000 | Ropinirole | Subjects who were treated on day 1-2 with 0.25 mg/day of ropinirole and on days 3-7 0.5 mg for 12 weeks if tolerated. After two weeks, dose could be increased weekly by 0.5mg a day up to 4 mg maximum dose. | | OG001 | Placebo | Subjects who took no investigational product. |
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| Secondary | Change From Average Baseline Scores of Subscale "Sleep Adequacy" of the Medical Outcomes Study Sleep Scale (MOS-SS)to Final Visit After 12 Weeks | Medical Outcome Study Sleep Scale (MOS-SS)-is a 12 item questionaire assessing sleep disturbance, sleep adequacy, somnolence, quantity of sleep, snoring, and awakening short of breath or with a headache. 10 question score from 1-6, 1 question scores 1-5 and 1 question asks average number of hours sleep each night. | Intent to Treat (ITT): All patients of the safety population with any psychometric data at baseline (within a single questionnaire) | Posted | | Mean | Standard Deviation | Score on a Scale | | Baseline and after Week 12 | | | | ID | Title | Description |
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| OG000 | Ropinirole | Subjects who were treated on day 1-2 with 0.25 mg/day of ropinirole and on days 3-7 0.5 mg for 12 weeks if tolerated. After two weeks, dose could be increased weekly by 0.5mg a day up to 4 mg maximum dose. | | OG001 | Placebo | Subjects who took no investigational product. |
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| Secondary | Change From Average Baseline Scores of Subscale "Sleep Quantity" (Hours) of the Medical Outcomes Study Sleep Scale (MOS-SS) to Final Visit After 12 Weeks | | Intent to Treat (ITT): All patients of the safety population with any psychometric data at baseline (within a single questionnaire) | Posted | | Mean | Standard Deviation | Score on a Scale | | Baseline and after Week 12 | | | | ID | Title | Description |
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| OG000 | Ropinirole | Subjects who were treated on day 1-2 with 0.25 mg/day of ropinirole and on days 3-7 0.5 mg for 12 weeks if tolerated. After two weeks, dose could be increased weekly by 0.5mg a day up to 4 mg maximum dose. | | OG001 | Placebo | Subjects who took no investigational product. |
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