Depressive Disorder, MajorNCT00285727
Ropinirole Controlled Release (CR) as an Adjunctive Agent in the Treatment of Major Depression
A study testing Ropinirole CR in people with Depressive Disorder, Major, run by Stanford University at 2 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Depressive Disorder, Major
- What is being tested?
- Ropinirole CR
- How many people
- 60 participants
- Where
- 2 sitesUnited States
- Study dates
- Jan 2006to Oct 2007
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
None listed.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Stanford University School of Medicine
Stanford, California, 94305
Depression Research Clinic, Psychiatry Department, Stanford School of Medicine
Stanford, California, 9430
About this study
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.
Read the 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.
- Conditions
- Depressive Disorder, Major
- Being tested
- Ropinirole CR
- Medical subject headings
- Depressive Disorder, Major
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ropinirole CRDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
HamD
Secondary outcomes (1)
MADRS
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2006 (estimated)
- Study startJan 2006
- Study completionOct 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Depressive Disorder, MajorStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Collaborators
- Duke University, GlaxoSmithKline
- Investigators
- Charles Debattista, Principal investigator, Depression Research Clinic, Psychiatry Department, Stanford School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00285727
- Sponsor's protocol ID
- 2969
- Status last verified
- May 2008
- First submitted
- 31 Jan 2006
- Last updated
- 19 May 2008
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ropinirole Controlled Release (CR) as an Adjunctive Agent in the Treatment of Major Depression
- ClinicalTrials.gov ID
- NCT00285727
- Acronym / sponsor ID
- 2969
- Conditions
- Depressive Disorder, Major
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Collaborators
- Duke University, GlaxoSmithKline
- Study start
- Jan 2006
- Study completion
- Oct 2007
- First posted
- 2 Feb 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ropinirole CR | Drug | – |
Primary outcome
HamD
1 secondary outcome
MADRS
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2008.
Related trials for Depressive Disorder, Major
Active, not recruitingPhase 4
Neural Circuit Effects of Ketamine in Depression
Major Depressive Disorder
Active, not recruiting
rTMS to Target Neural Connectivity and Rumination in Treatment-Resistant Depression
Depression, Treatment Resistant
Recruiting
Peer-Delivered Behavioral Activation in a CCBHC
Major Depressive Disorder, Substance Use Disorders
RecruitingPhase 3
Efficacy of Statins Among Major Depressive Disorder
Major Depressive Disorder, MDD
Recruiting
IMST for Dementia Risk Reduction
Systolic Blood Pressure, Blood Pressure
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Charles Debattista principal investigator
Depression Research Clinic, Psychiatry Department, Stanford School of Medicine
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ropinirole CR in people with Depressive Disorder, Major, run by Stanford University at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 May 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
HamD. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 May 2008.