Bipolar DisorderPhase 4NCT00335205
A Placebo Controlled Trial of the Dopamine D-2 Receptor Agonist Ropinirole in Treatment of 60 Patients With Refractory Bipolar Depression.
A Phase 4 study testing ropinirole in people with Bipolar Disorder and Major Depressive Disorder, run by Sheba Medical Center at 2 sites in Israel.
Trial summary
We hypothesize that depressed patients who have not responded to their current antidepressant medication will respond to the addition of ropinirole to their current regimen at a rate better than placebo. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bipolar Disorder, Major Depressive Disorder
- What is being tested?
- ropinirole
- How many people
- 60 participants
- Where
- 2 sitesIsrael
- Study dates
- Apr 2003to not given
- Phase
- Phase 4
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- DSM-IV Major Depression OR Bipolar I or II Disorder - Currently Depressed
- One month of a stable, adequate dose of antidepressant medication
- Bipolar patients must have a mood stabilizer
- At least 18 years old
- Modified HDRS-21 more than 16 (Scores reverse vegetative symptoms.)
- Informed Consent
Who cannot join
- CVA
- Antipsychotic Medication
- Drug or Alcohol Abuse
- Active Suicidality
- Rapid Cycling Bipolar Disorder
- Neurologic or Dementing Illness
Show all 9Show fewer
- Psychosis
- Parkinsonism
- Pregnancy
Trial locations and contacts
2 sites in 1 country.
Israel2 sites, 1 recruiting
- Active, not recruiting
Jerusalem Mental Health Center
Jerusalem
- Recruiting
Chaim Sheba Medical Center, Dept. of Psychiatry
Tel HaShomer, 52621
Ari A Gershon, MD, +972-3-5349105, agershon@sheba.health.gov.il
About this study
Official title: A Placebo Controlled Trial of the Dopamine D-2 Receptor Agonist Ropinirole in Treatment of 60 Patients With Refractory Bipolar I and II Depression.
We hypothesize that depressed patients who have not responded to their current antidepressant medication will respond to the addition of ropinirole to their current regimen at a rate better than placebo.
Read the detailed description
Most pharmacologic treatments of depression rely on serotonergic and/or noradrenergic mechanisms. Yet, evidence both from animal studies and from human trials suggests a role for dopaminergic pathways and particularly for dopamine D2-like receptors in the treatment of depression. In recent years, two new selective agonists of dopamine D2-like receptors have come into clinical use for the treatment of parkinsonism. Preliminary evidence suggests that these drugs might be useful as antidepressants. We are testing whether one of these agonists, ropinirole, is an effective augmentation strategy in depressed patients in a double-blind, randomized, controlled trial. We are recruiting unipolar and bipolar patients who remained depressed (modified Hamilton Depression Rating Scale score greater than 16) despite at least 4 weeks of treatment with an adequate dose of antidepressant medication. Patients receive either 2mg of oral ropinirole or placebo twice daily added on to their current medication and are evaluated weekly over 7 weeks and are assessed weekly using two depression rating scales.
- Conditions
- Bipolar Disorder, Major Depressive Disorder
- Being tested
- ropinirole
- Keywords
- ropinirole, dopamine, D2, depression, bipolar
- Medical subject headings
- Bipolar Disorder, Depressive Disorder, Major, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ropiniroleDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Hamilton Depression Rating Scale Score
Secondary outcomes (1)
Montgomery Asberg Depression Rating Scale Score
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2006 (estimated)
- Study startApr 2003
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bipolar DisorderStudies of the same condition, open and under way.
- More trials run by Sheba Medical CenterThe 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 60 participants
Sponsor and investigators
- Lead sponsor
- Sheba Medical Center
- Sponsor type
- Other government
- Collaborators
- Jerusalem Mental Health Center
- Investigators
- Leon Grunhaus, MD, Principal investigator, Jerusalem Mental Health Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00335205
- Sponsor's protocol ID
- SHEBA-02-2690-LG-CTIL
- Status last verified
- Jun 2006
- First submitted
- 8 Jun 2006
- Last updated
- 9 Jun 2006
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Placebo Controlled Trial of the Dopamine D-2 Receptor Agonist Ropinirole in Treatment of 60 Patients With Refractory Bipolar I and II Depression.
- ClinicalTrials.gov ID
- NCT00335205
- Acronym / sponsor ID
- SHEBA-02-2690-LG-CTIL
- Conditions
- Bipolar Disorder, Major Depressive Disorder
- Keywords
- ropinirole, dopamine, D2, depression, bipolar
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants
- Lead sponsor
- Sheba Medical CenterOther government
- Collaborators
- Jerusalem Mental Health Center
- Study start
- Apr 2003
- First posted
- 9 Jun 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.
We hypothesize that depressed patients who have not responded to their current antidepressant medication will respond to the addition of ropinirole to their current regimen at a rate better than placebo.
Detailed description
Most pharmacologic treatments of depression rely on serotonergic and/or noradrenergic mechanisms. Yet, evidence both from animal studies and from human trials suggests a role for dopaminergic pathways and particularly for dopamine D2-like receptors in the treatment of depression. In recent years, two new selective agonists of dopamine D2-like receptors have come into clinical use for the treatment of parkinsonism. Preliminary evidence suggests that these drugs might be useful as antidepressants. We are testing whether one of these agonists, ropinirole, is an effective augmentation strategy in depressed patients in a double-blind, randomized, controlled trial. We are recruiting unipolar and bipolar patients who remained depressed (modified Hamilton Depression Rating Scale score greater than 16) despite at least 4 weeks of treatment with an adequate dose of antidepressant medication. Patients receive either 2mg of oral ropinirole or placebo twice daily added on to their current medication and are evaluated weekly over 7 weeks and are assessed weekly using two depression rating scales.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- DSM-IV Major Depression OR Bipolar I or II Disorder - Currently Depressed
- One month of a stable, adequate dose of antidepressant medication
- Bipolar patients must have a mood stabilizer
- At least 18 years old
- Modified HDRS-21 more than 16 (Scores reverse vegetative symptoms.)
Key exclusion criteria (9 listed)
- CVA
- Antipsychotic Medication
- Drug or Alcohol Abuse
- Active Suicidality
- Rapid Cycling Bipolar Disorder
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 | Drug | – |
Primary outcome
Hamilton Depression Rating Scale Score
1 secondary outcome
Montgomery Asberg Depression Rating Scale Score
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2006.
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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.
Leon Grunhaus, MD principal investigator
Jerusalem Mental Health Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing ropinirole in people with Bipolar Disorder and Major Depressive Disorder, run by Sheba Medical Center at 2 sites in Israel.
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 9 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: status not confirmed, as of the sponsor's last update on 9 Jun 2006. 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 Israel. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ari A Gershon, MD (+972-3-5349105, agershon@sheba.health.gov.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hamilton Depression Rating Scale Score. 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 9 Jun 2006.