The Effects Of Ropinirole On Mood Or Mild Depression In Patients With Moderate To Severe Restless Legs Syndrome - Study Results

Study Type:	Interventional
Study Design:	Randomized, Double-Blind, Parallel Assignment
Condition:	Moderate to Severe Idiopathic Restless Legs Syndrome (RLS)
Intervention:	Drug: Ropinirole

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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	Ropinirole	Placebo
STARTED	199^[1]	67
COMPLETED	145	38
NOT COMPLETED	54	29
Did not meet inclusion criteria	5	3
Adverse Event	34	6
Withdrawal by Subject	8	7
Non-compliance	1	2
Lack of Efficacy	2	8
Met Exclusion Criteria	3	1
Other	1	1
Increase of RLS Symptoms	0	1

[1]	199 were randomized. Only 198 took investigational product.

	Ropinirole	Placebo	Total
Number of Participants [units: participants]	198	67	265
Age [units: Years] Mean ± Standard Deviation	58.2 ± 11.4	59.5 ± 11.3	58.5 ± 11.4
Gender [units: Participants]
Female	144	45	189
Male	54	22	76

Outcome Measures

1. Primary:

Average Change of the MADRS (Montgomery-Asberg Depression Rating Scale) Total Score From Baseline to Final Visit After 12 Weeks of Treatment [ Baseline and Week 12 ]

Measure Type	Primary
Measure Title	Average Change of the MADRS (Montgomery-Asberg Depression Rating Scale) Total Score From Baseline to Final Visit After 12 Weeks of Treatment
Measure Description	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.
Time Frame	Baseline and Week 12
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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.

Reporting Groups

	Description
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.
Placebo	Subjects who took no investigational product.

Measured Values

	Ropinirole	Placebo
Number of Participants Analyzed [units: participants]	171	60
Average Change of the MADRS (Montgomery-Asberg Depression Rating Scale) Total Score From Baseline to Final Visit After 12 Weeks of Treatment [units: Score on a Scale] Mean ± Standard Deviation	-10.1 ± 7.3	-6.5 ± 7.6

Statistical Analysis 1 for Average Change of the MADRS (Montgomery-Asberg Depression Rating Scale) Total Score From Baseline to Final Visit After 12 Weeks of Treatment

Groups ^[1]	All groups
Method ^[2]	ANCOVA
P Value ^[3]	<0.001
Mean Difference (Final Values) ^[4]	-3.6
95% Confidence Interval	( -5.6 to -1.6 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
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[2]	Other relevant information, such as adjustments or degrees of freedom:
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[3]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
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[4]	Other relevant estimation information:
	Mean difference = Ropinirole minus Placebo. Used adjusted change from baseline.

2. 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) [ Baseline and Week 12 ]

Measure Type	Secondary
Measure Title	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)
Measure Description	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.
Time Frame	Baseline and Week 12
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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.

Reporting Groups

	Description
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.
Placebo	Subjects who took no investigational product.

Measured Values

	Ropinirole	Placebo
Number of Participants Analyzed [units: participants]	91	29
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) [units: Score on a Scale] Mean ± Standard Deviation	-12.5 ± 8.0	-8.8 ± 9.2

No statistical analysis provided for 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)

3. 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 [ Baseline and Week 12 ]

Measure Type	Secondary
Measure Title	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
Measure Description	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).
Time Frame	Baseline and Week 12
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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.

Reporting Groups

	Description
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.
Placebo	Subjects who took no investigational product.

Measured Values

	Ropinirole	Placebo
Number of Participants Analyzed [units: participants]	166	55
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 [units: Score on a Scale] Mean ± Standard Deviation	-8.2 ± 5.5	-5.5 ± 6.4

No statistical analysis provided for 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

4. 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 [ Baseline and Week 12 ]

Measure Type	Secondary
Measure Title	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
Measure Description	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).
Time Frame	Baseline and Week 12
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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

Reporting Groups

	Description
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.
Placebo	Subjects who took no investigational product.

Measured Values

	Ropinirole	Placebo
Number of Participants Analyzed [units: participants]	93	33
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 [units: Score on a Scale] Mean ± Standard Deviation	-9.6 ± 5.9	-7.2 ± 6.6

No statistical analysis provided for 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

5. Secondary:

Average Change of the Beck Depression Inventory (BDI) Total Score From Baseline to Final Visit After 12 Weeks of Treatment [ Baseline and Week 12 ]

Measure Type	Secondary
Measure Title	Average Change of the Beck Depression Inventory (BDI) Total Score From Baseline to Final Visit After 12 Weeks of Treatment
Measure Description	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.
Time Frame	Baseline and Week 12
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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.

Reporting Groups

	Description
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.
Placebo	Subjects who took no investigational product.

Measured Values

	Ropinirole	Placebo
Number of Participants Analyzed [units: participants]	169	60
Average Change of the Beck Depression Inventory (BDI) Total Score From Baseline to Final Visit After 12 Weeks of Treatment [units: Score on a Scale] Mean ± Standard Deviation	-8.6 ± 7.0	-6.5 ± 7.8

No statistical analysis provided for Average Change of the Beck Depression Inventory (BDI) Total Score From Baseline to Final Visit After 12 Weeks of Treatment

6. 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 [ Baseline and Week 12 ]

Measure Type	Secondary
Measure Title	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
Measure Description	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.
Time Frame	Baseline and Week 12
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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.

Reporting Groups

	Description
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.
Placebo	Subjects who took no investigational product.

Measured Values

	Ropinirole	Placebo
Number of Participants Analyzed [units: participants]	75	28
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 [units: Score on a Scale] Mean ± Standard Deviation	-10.9 ± 7.9	-9.9 ± 9.0

No statistical analysis provided for 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

7. Secondary:

Percentage of Participants With at Least Moderate Depression (MADRS Score >= 18) at Baseline and in Week 12 [ Baseline and Week 12 ]

Measure Type	Secondary
Measure Title	Percentage of Participants With at Least Moderate Depression (MADRS Score >= 18) at Baseline and in Week 12
Measure Description	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.
Time Frame	Baseline and Week 12
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Modified Intent to Treat (mITT): All treated patients with MADRS score at baseline and post baseline (i.e., at week 12).

Reporting Groups

	Description
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.
Placebo	Subjects who took no investigational product.

Measured Values

	Ropinirole	Placebo
Number of Participants Analyzed [units: participants]	171	60
Percentage of Participants With at Least Moderate Depression (MADRS Score >= 18) at Baseline and in Week 12 [units: Percentage of Participants]	11.7	23.3

No statistical analysis provided for Percentage of Participants With at Least Moderate Depression (MADRS Score >= 18) at Baseline and in Week 12

8. Secondary:

Percentage of Participants With at Least Moderate Depression (HAM-D >= 15) at Baseline and in Week 12 [ Baseline and Week 12 ]

Measure Type	Secondary
Measure Title	Percentage of Participants With at Least Moderate Depression (HAM-D >= 15) at Baseline and in Week 12
Measure Description	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).
Time Frame	Baseline and Week 12
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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.

Reporting Groups

	Description
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.
Placebo	Subjects who took no investigational product.

Measured Values

	Ropinirole	Placebo
Number of Participants Analyzed [units: participants]	168	56
Percentage of Participants With at Least Moderate Depression (HAM-D >= 15) at Baseline and in Week 12 [units: Percentage of Participants]	10.7	26.8

No statistical analysis provided for Percentage of Participants With at Least Moderate Depression (HAM-D >= 15) at Baseline and in Week 12

9. Secondary:

Percentage of Participants (“Responder”) With a Decrease of MADRS Total Score of at Least 6 Points After 12 Weeks Compared to Baseline [ Baseline and Week 12 ]

Measure Type	Secondary
Measure Title	Percentage of Participants (“Responder”) With a Decrease of MADRS Total Score of at Least 6 Points After 12 Weeks Compared to Baseline
Measure Description	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.
Time Frame	Baseline and Week 12
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Modified Intent to Treat (mITT): All treated patients with MADRS score at baseline and post baseline (i.e., at visit 4 and/or 5).

Reporting Groups

	Description
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.
Placebo	Subjects who took no investigational product.

Measured Values

	Ropinirole	Placebo
Number of Participants Analyzed [units: participants]	171	60
Percentage of Participants (“Responder”) With a Decrease of MADRS Total Score of at Least 6 Points After 12 Weeks Compared to Baseline [units: Percentage of Participants]	74.9	48.3

No statistical analysis provided for Percentage of Participants (“Responder”) With a Decrease of MADRS Total Score of at Least 6 Points After 12 Weeks Compared to Baseline

10. 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) [ Baseline and Week 12 ]

Measure Type	Secondary
Measure Title	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)
Measure Description	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.
Time Frame	Baseline and Week 12
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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

Reporting Groups

	Description
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.
Placebo	Subjects who took no investigational product.

Measured Values

	Ropinirole	Placebo
Number of Participants Analyzed [units: participants]	91	29
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) [units: Percentage of Participants]	80.2	58.6

No statistical analysis provided for 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)

11. 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) [ Baseline and Week 12 ]

Measure Type	Secondary
Measure Title	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)
Measure Description	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.
Time Frame	Baseline and Week 12
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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

Reporting Groups

	Description
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.
Placebo	Subjects who took no investigational product.

Measured Values

	Ropinirole	Placebo
Number of Participants Analyzed [units: participants]	93	34
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) [units: Score on a Scale] Mean ± Standard Deviation	-11.6 ± 7.7	-7.6 ± 8.1

No statistical analysis provided for 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)

12. 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) [ Baseline and Week 12 ]

Measure Type	Secondary
Measure Title	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)
Measure Description	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).
Time Frame	Baseline and Week 12
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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.

Reporting Groups

	Description
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.
Placebo	Subjects who took no investigational product.

Measured Values

	Ropinirole	Placebo
Number of Participants Analyzed [units: participants]	90	31
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) [units: Score on a Scale] Mean ± Standard Deviation	-9.2 ± 5.6	-6.5 ± 7.0

No statistical analysis provided for 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)

13. 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) [ Baseline and Week 12 ]

Measure Type	Secondary
Measure Title	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)
Measure Description	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.
Time Frame	Baseline and Week 12
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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.

Reporting Groups

	Description
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.
Placebo	Subjects who took no investigational product.

Measured Values

	Ropinirole	Placebo
Number of Participants Analyzed [units: participants]	91	34
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) [units: Score on a Scale] Mean ± Standard Deviation	-10.4 ± 6.8	-7.2 ± 8.2

No statistical analysis provided for 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)

14. Secondary:

Change in Average International Restless Legs Scale for Severity (IRLS) Scores in All Participants From Baseline to After 1, 4, and 12 Weeks [ Baseline, Week 1, Week 4, Week 12 ]

Measure Type	Secondary
Measure Title	Change in Average International Restless Legs Scale for Severity (IRLS) Scores in All Participants From Baseline to After 1, 4, and 12 Weeks
Measure Description	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
Time Frame	Baseline, Week 1, Week 4, Week 12
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Intent to Treat (ITT): All patients of the safety population with any psychometric data at baseline (within a single questionnaire)

Reporting Groups

	Description
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.
Placebo	Subjects who took no investigational product.

Measured Values

	Ropinirole	Placebo
Number of Participants Analyzed [units: participants]	171	60
Change in Average International Restless Legs Scale for Severity (IRLS) Scores in All Participants From Baseline to After 1, 4, and 12 Weeks [units: Score on a Scale] Mean ± Standard Deviation
Change from Baseline after 1 Week	-7.7 ± 8.0	-4.1 ± 5.4
Change from Baseline after 4 Weeks	-14.0 ± 9.2	-8.6 ± 8.5
Change from Baseline after 12 Weeks	-14.6 ± 9.2	-10.2 ± 10.6

No statistical analysis provided for Change in Average International Restless Legs Scale for Severity (IRLS) Scores in All Participants From Baseline to After 1, 4, and 12 Weeks

15. 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 [ Week 1, Week 4, Week 12 ]

Measure Type	Secondary
Measure Title	Percentage of Participants With a Decrease of International Restless Legs Scale (IRLS) Scores of at Least 6 Points After 1, 4 and 12 Weeks
Measure Description	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
Time Frame	Week 1, Week 4, Week 12
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Intent to Treat (ITT): All patients of the safety population with any psychometric data at baseline (within a single questionnaire)

Reporting Groups

	Description
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.
Placebo	Subjects who took no investigational product.

Measured Values

	Ropinirole	Placebo
Number of Participants Analyzed [units: participants]	171	60
Percentage of Participants With a Decrease of International Restless Legs Scale (IRLS) Scores of at Least 6 Points After 1, 4 and 12 Weeks [units: Percentage of Participants]
1 Week	52.6	28.3
4 Weeks	80.7	58.3
12 Weeks	84.8	61.7

No statistical analysis provided for Percentage of Participants With a Decrease of International Restless Legs Scale (IRLS) Scores of at Least 6 Points After 1, 4 and 12 Weeks

16. 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 [ Week 1, Week 4, Week 12 ]

Measure Type	Secondary
Measure Title	Percentage of Participants With “Much Improved” or “Very Much Improved” on the Clinical Global Impression-Global Improvement Scale After 1, 4 and 12 Weeks
Measure Description	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.
Time Frame	Week 1, Week 4, Week 12
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Intent to Treat (ITT): All patients of the safety population with any psychometric data at baseline (within a single questionnaire)

Reporting Groups

	Description
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.
Placebo	Subjects who took no investigational product.

Measured Values

	Ropinirole	Placebo
Number of Participants Analyzed [units: participants]	171	60
Percentage of Participants With “Much Improved” or “Very Much Improved” on the Clinical Global Impression-Global Improvement Scale After 1, 4 and 12 Weeks [units: Percentage of Participants]
Week 1	35.1	15.0
Week 4	66.7	40.0
Week 12	64.3	46.7

No statistical analysis provided for Percentage of Participants With “Much Improved” or “Very Much Improved” on the Clinical Global Impression-Global Improvement Scale After 1, 4 and 12 Weeks

17. 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 [ Baseline and after Week 12 ]

Measure Type	Secondary
Measure Title	Change From Average Baseline Score of Subscale of “Somnolence” in the Medical Outcomes Study Sleep Scale (MOS-SS) to Final Visit After 12 Weeks
Measure Description	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.
Time Frame	Baseline and after Week 12
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Intent to Treat (ITT): All patients of the safety population with any psychometric data at baseline (within a single questionnaire)

Reporting Groups

	Description
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.
Placebo	Subjects who took no investigational product.

Measured Values

	Ropinirole	Placebo
Number of Participants Analyzed [units: participants]	171	59
Change From Average Baseline Score of Subscale of “Somnolence” in the Medical Outcomes Study Sleep Scale (MOS-SS) to Final Visit After 12 Weeks [units: Score on a Scale] Mean ± Standard Deviation	-12.5 ± 19.4	-10.2 ± 19.9

No statistical analysis provided for Change From Average Baseline Score of Subscale of “Somnolence” in the Medical Outcomes Study Sleep Scale (MOS-SS) to Final Visit After 12 Weeks

18. 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 [ Baseline and after Week 12 ]

Measure Type	Secondary
Measure Title	Change From Average Baseline Scores of Subscale “Sleep Disturbance” of the Medical Outcomes Study Sleep Scale (MOS-SS) to Final Visit After 12 Weeks
Measure Description	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.
Time Frame	Baseline and after Week 12
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Intent to Treat (ITT): All patients of the safety population with any psychometric data at baseline (within a single questionnaire)

Reporting Groups

	Description
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.
Placebo	Subjects who took no investigational product.

Measured Values

	Ropinirole	Placebo
Number of Participants Analyzed [units: participants]	167	59
Change From Average Baseline Scores of Subscale “Sleep Disturbance” of the Medical Outcomes Study Sleep Scale (MOS-SS) to Final Visit After 12 Weeks [units: Score on a Scale] Mean ± Standard Deviation	-30.5 ± 24.5	-15.8 ± 27.6

No statistical analysis provided for Change From Average Baseline Scores of Subscale “Sleep Disturbance” of the Medical Outcomes Study Sleep Scale (MOS-SS) to Final Visit After 12 Weeks

19. 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 [ Baseline and after Week 12 ]

Measure Type	Secondary
Measure Title	Change From Average Baseline Scores of Subscale “Sleep Adequacy” of the Medical Outcomes Study Sleep Scale (MOS-SS)to Final Visit After 12 Weeks
Measure Description	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.
Time Frame	Baseline and after Week 12
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Intent to Treat (ITT): All patients of the safety population with any psychometric data at baseline (within a single questionnaire)

Reporting Groups

	Description
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.
Placebo	Subjects who took no investigational product.

Measured Values

	Ropinirole	Placebo
Number of Participants Analyzed [units: participants]	170	59
Change From Average Baseline Scores of Subscale “Sleep Adequacy” of the Medical Outcomes Study Sleep Scale (MOS-SS)to Final Visit After 12 Weeks [units: Score on a Scale] Mean ± Standard Deviation	34.0 ± 30.6	15.6 ± 36.2

No statistical analysis provided for Change From Average Baseline Scores of Subscale “Sleep Adequacy” of the Medical Outcomes Study Sleep Scale (MOS-SS)to Final Visit After 12 Weeks

20. 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 [ Baseline and after Week 12 ]

Measure Type	Secondary
Measure Title	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
Measure Description	No text entered.
Time Frame	Baseline and after Week 12
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Intent to Treat (ITT): All patients of the safety population with any psychometric data at baseline (within a single questionnaire)

Reporting Groups

	Description
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.
Placebo	Subjects who took no investigational product.

Measured Values

	Ropinirole	Placebo
Number of Participants Analyzed [units: participants]	170	59
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 [units: Score on a Scale] Mean ± Standard Deviation	1.3 ± 1.3	0.5 ± 1.4

No statistical analysis provided for 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

Responsible Party:	GSK ( Study Director )
Study ID Numbers:	RRL106721, EudraCT:2005-006080-31
Study First Received:	July 25, 2006
Results First Received:	December 12, 2008
Last Updated:	August 11, 2009
ClinicalTrials.gov Identifier:	NCT00357097 History of Changes
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices