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

NCT00357097 | Completed Phase 3 Results

• 1 other identifier: RRL106721
• Study Type: interventional
• Target: 240
• Locations: 1 country
• Sites: 50

Brief Summary

Ropinirole has shown to improve mood in depressed patients as well as to improve the symptoms of Restless Legs Syndrome. Up to 40% of RLS patients suffer from mild depression, therefore it would be important for decisions no therapy to know whether a drug could improve both depressive and RLS symptoms.

Conditions

Restless Legs Syndrome; Moderate to Severe Idiopathic Restless Legs Syndrome (RLS)

Keywords

randomised; ropinirole; depression; RLS; placebo; mood; double-blind; restless legs syndrome; germany

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline and Week 12

Secondary Outcomes (19)

• 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

• 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

• 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

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

  Baseline and Week 12

• 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

Interventions

Ropinirole DRUG

Eligibility Criteria

• Age: 18 Years - 79 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• diagnosis of idiopathic Restless Legs Syndrome, confirmed by a score of at least 11 on the RLS Diagnostic Index
• certain severity of symptoms (at least score of 15 on the International Restless Legs Score (IRLS)
• Have had RLS symptoms for at least 15 nights in the last four weeks.
• \< 6 hours of sleep in nights with RLS symptoms
• MADRS (depression rating scale) score of at least 12 (= borderline to depression) at baseline

You may not qualify if:

• any other sleep disorder that might interfere with the RLS symptoms or sleep (e.g. sleep apnea disorder, narcolepsy)
• Secondary RLS due to diagnosis of renal insufficiency, polyneuropathy, pregnancy (see below), iron deficiency anemia
• Current or past suicidality
• medication known to trigger/aggravate/ cause or interfere with RLS symptoms (e.g. most antidepressants, lithium, neuroleptics, opioids, carbidopa, clonidine, antihistamines, anticonvulsants etc.).
• daytime RLS symptoms which require treatment (daytime: 10 a.m. until 6 p.m.).
• concomitant movement disorders (e.g. Parkinson's Disease, dyskinesia, dystonia).
• medical conditions with symptoms which could affect assessments of efficacy (e.g. diabetes, rheumatoid arthritis, fibromyalgia syndrome, cancer etc.).
• Subjects taking any medication known to induce drowsiness or to affect sleep.
• Subjects who are pregnant, lactating or of childbearing potential. Women of childbearing potential must use adequate contraception
• clinically significant or unstable medical conditions (e.g. severe heart disease, severe liver or kidney disease etc.).
• pain syndromes, caused by other disorders than RLS
• excessive caffeine intake
• diastolic blood pressure \>110mmHg or \<50mmHg or systolic blood pressure \>180mmHg or \<90mmHg at baseline.
• Withdrawal, introduction, or change in dose of hormone replacement therapy (HRT) or the oral contraceptive pill (OCP) and/or certain drugs which are known to interact with ropinirole (e.g. ciprofloxacin, cimetidine, tobacco, omeprazole).

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (50)

GSK Investigational Site

Ellwangen, Baden-Wurttemberg, 73479, Germany

Location

GSK Investigational Site

Freiburg im Breisgau, Baden-Wurttemberg, 79104, Germany

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GSK Investigational Site

Ostfildern, Baden-Wurttemberg, 73760, Germany

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GSK Investigational Site

Ulm, Baden-Wurttemberg, 89073, Germany

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GSK Investigational Site

Ulm, Baden-Wurttemberg, 89081, Germany

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GSK Investigational Site

Munich, Bavaria, 80331, Germany

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GSK Investigational Site

Nuremberg, Bavaria, 90403, Germany

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GSK Investigational Site

Regensburg, Bavaria, 93053, Germany

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GSK Investigational Site

Unterhaching, Bavaria, 82008, Germany

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GSK Investigational Site

Würzburg, Bavaria, 97070, Germany

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GSK Investigational Site

Bad Saarow, Brandenburg, 15526, Germany

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GSK Investigational Site

Bad Homburg, Hesse, 61348, Germany

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GSK Investigational Site

Butzbach, Hesse, 35510, Germany

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GSK Investigational Site

Herborn, Hesse, 35745, Germany

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GSK Investigational Site

Kassel, Hesse, 34128, Germany

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GSK Investigational Site

Achim, Lower Saxony, 28832, Germany

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GSK Investigational Site

Göttingen, Lower Saxony, 37073, Germany

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GSK Investigational Site

Göttingen, Lower Saxony, 37075, Germany

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GSK Investigational Site

Hildesheim, Lower Saxony, 31134, Germany

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GSK Investigational Site

Wolfsburg, Lower Saxony, 38440, Germany

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GSK Investigational Site

Anklam, Mecklenburg-Vorpommern, 17389, Germany

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GSK Investigational Site

Schwerin, Mecklenburg-Vorpommern, 19053, Germany

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GSK Investigational Site

Wismar, Mecklenburg-Vorpommern, 23966, Germany

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GSK Investigational Site

Bielefeld, North Rhine-Westphalia, 33647, Germany

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GSK Investigational Site

Bochum, North Rhine-Westphalia, 44787, Germany

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GSK Investigational Site

Bochum, North Rhine-Westphalia, 44791, Germany

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GSK Investigational Site

Bochum, North Rhine-Westphalia, 44805, Germany

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GSK Investigational Site

Bochum, North Rhine-Westphalia, 44809, Germany

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GSK Investigational Site

Bochum, North Rhine-Westphalia, 44892, Germany

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GSK Investigational Site

Düren, North Rhine-Westphalia, 52349, Germany

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GSK Investigational Site

Düsseldorf, North Rhine-Westphalia, 40212, Germany

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GSK Investigational Site

Gelsenkirchen, North Rhine-Westphalia, 45879, Germany

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GSK Investigational Site

Gütersloh, North Rhine-Westphalia, 33330, Germany

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GSK Investigational Site

Hattingen, North Rhine-Westphalia, 45525, Germany

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GSK Investigational Site

Jülich, North Rhine-Westphalia, 52428, Germany

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GSK Investigational Site

Limburgerhof, Rhineland-Palatinate, 67117, Germany

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GSK Investigational Site

Dresden, Saxony, 01307, Germany

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GSK Investigational Site

Halle, Saxony-Anhalt, 06118, Germany

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GSK Investigational Site

Köthen, Saxony-Anhalt, 06366, Germany

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GSK Investigational Site

Oldenburg in Holstein, Schleswig-Holstein, 26122, Germany

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GSK Investigational Site

Berlin, State of Berlin, 10117, Germany

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GSK Investigational Site

Berlin, State of Berlin, 10625, Germany

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GSK Investigational Site

Berlin, State of Berlin, 10629, Germany

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GSK Investigational Site

Berlin, State of Berlin, 10787, Germany

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GSK Investigational Site

Berlin, State of Berlin, 10969, Germany

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GSK Investigational Site

Berlin, State of Berlin, 12167, Germany

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GSK Investigational Site

Berlin, State of Berlin, 13053, Germany

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GSK Investigational Site

Berlin, State of Berlin, 13156, Germany

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GSK Investigational Site

Gera, Thuringia, 07551, Germany

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GSK Investigational Site

Jena, Thuringia, 07743, Germany

Location

MeSH Terms

Conditions

Restless Legs Syndrome; Depression

Interventions

ropinirole

Condition Hierarchy (Ancestors)

Nervous System Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Parasomnias; Mental Disorders; Behavioral Symptoms; Behavior

Results Point of Contact

• Title: GSK Response Center
• Organization: GlaxoSmithKline

866-435-7343

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 25, 2006
• First Posted: July 27, 2006
• Study Start: June 1, 2006
• Primary Completion: December 1, 2007
• Study Completion: December 1, 2007
• Last Updated: June 7, 2012
• Results First Posted: September 16, 2009

Record last verified: 2011-05

Locations

DE (50)