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

Participant Flow

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

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

Baseline Characteristics

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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.

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

Outcome Measures

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1. Primary:

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

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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)

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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

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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

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5. Secondary:

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

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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

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7. Secondary:

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

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8. Secondary:

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

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9. Secondary:

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

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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)

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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)

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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)

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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)

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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

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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

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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

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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

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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

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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

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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

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Serious Adverse Events

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Other Adverse Events

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More Information

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Certain Agreements:

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

The agreement is:

	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed. Restriction Description: GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centres of a multi-centre trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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Results Point of Contact:

Name/Title: GSK Response Center
Organization: GlaxoSmithKline
phone: 866-435-7343

No publications provided

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