- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00285727
Ropinirole Controlled Release (CR) as an Adjunctive Agent in the Treatment of Major Depression
May 16, 2008 updated by: Stanford University
This is an 8 week study for patients who are currently taking antidepressant medication but not fully responding.
Ropinirole CR would be taken in conjunction with current antidepressant medication.
Patients come into the clinic once a week when starting on the medication and then once every other week for the remainder of the 8 weeks.
Study Overview
Detailed Description
We hope to learn whether ropinirole CR (controlled release formulation) is safe and effective when taken with an antidepressant to reduce the symptoms of depression.
Adults who have a diagnosis of major depression and are currently taking an adequate dose of antidepressant medication will be sought for participation.
They will continue to take the antidepressant medication and will receive ropinirole CR, an investigational medication, for eight weeks during which information will be collected about mood and cognitive functioning.
Study Type
Interventional
Enrollment
60
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
California
-
Stanford, California, United States, 94305
- Stanford University School of Medicine
-
Stanford, California, United States, 9430
- Depression Research Clinic, Psychiatry Department, Stanford School of Medicine
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Age 18 to 65 years old
- Currently experiencing major depression
- On at least an adequate dose of fluoxetine, paroxetine, sertraline, citalopram, escitalopram, venlafaxine, bupropion, mirtazapine or duloxetine for at least 6 weeks (monotherapy). Exclusion Criteria:1. Pregnant females or females of child bearing years not using adequate birth control in the opinion of the investigators
- Known sensitivity to ropinirole
- Significant medical conditions that would preclude safe participation in the study in the opinion of the investigators.
- Significant abnormalities observed in screening laboratory evaluation
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
---|
HamD
|
Secondary Outcome Measures
Outcome Measure |
---|
MADRS
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Charles Debattista, Depression Research Clinic, Psychiatry Department, Stanford School of Medicine
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2006
Study Completion
October 1, 2007
Study Registration Dates
First Submitted
January 31, 2006
First Submitted That Met QC Criteria
February 1, 2006
First Posted (Estimate)
February 2, 2006
Study Record Updates
Last Update Posted (Estimate)
May 19, 2008
Last Update Submitted That Met QC Criteria
May 16, 2008
Last Verified
May 1, 2008
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2969
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Depressive Disorder, Major
-
Shalvata Mental Health CenterUnknownMAjor Depressive DisorderIsrael
-
York UniversityCentre for Addiction and Mental HealthSuspendedDisorder, Major DepressiveCanada
-
Seasons Biotechnology (Taizhou) Co., Ltd.CompletedMajor Depressive Disorder (MDDIndia
-
Gangnam Severance HospitalCompletedMajor Depressive Disorder(MDD)Korea, Republic of
-
University College, LondonCompletedUnipolar Major Depressive DisorderUnited Kingdom
-
Fundació Institut de Recerca de l'Hospital de la...Fondo de Investigacion SanitariaUnknown
-
Seasons Biotechnology (Taizhou) Co., Ltd.CompletedMajor Depressive Disorder (MDD)India
-
Repurposed Therapeutics, Inc.Unknown
-
GlaxoSmithKlineCompletedMajor Depressive Disorder (MDD)United States
-
AccexibleRecruitingMajor Depressive Disorder (MDD)Spain
Clinical Trials on Ropinirole CR
-
GlaxoSmithKlineCompletedRestless Legs Syndrome | Restless Legs Syndrome (RLS)United States
-
GlaxoSmithKlineTerminated
-
GlaxoSmithKlineCompletedRestless Legs SyndromeJapan
-
GlaxoSmithKlineCompleted12-week Polysomnography Study of Ropinirole Controlled Release for Restless Legs Syndrome ((CR-RLS))Restless Legs Syndrome | Restless Legs Syndrome (RLS)United States
-
GlaxoSmithKlineCompletedParkinson's Disease | Parkinson DiseaseUnited States, Spain, Poland, France, Belgium, Hungary, United Kingdom, Italy, Czech Republic
-
Lupin Ltd.CompletedPharmacokinetic StudyIndia
-
GlaxoSmithKlineCompleted
-
GlaxoSmithKlineCompletedParkinson's Disease | Parkinson Disease | DyskinesiasUnited States