Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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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.

Participant Flow:   Overall Study

	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

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.

Baseline Measures

	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

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 ]

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 ]

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 ]

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 ]

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 ]

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 ]

7.  Secondary:

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

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 ]

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 ]

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 ]

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 ]

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 ]

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 ]

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 ]

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 ]

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 ]

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 ]

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 ]

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 ]