Ignite Creation Date:
2025-12-25 @ 3:15 AM
Ignite Modification Date:
2025-12-26 @ 1:54 AM
Study NCT ID:
NCT00335205
Status:
UNKNOWN
Last Update Posted:
2006-06-09
First Post:
2006-06-08
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Placebo Controlled Trial of the Dopamine D-2 Receptor Agonist Ropinirole in Treatment of 60 Patients With Refractory Bipolar Depression.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001714', 'term': 'Bipolar Disorder'}, {'id': 'D003865', 'term': 'Depressive Disorder, Major'}, {'id': 'D003863', 'term': 'Depression'}], 'ancestors': [{'id': 'D000068105', 'term': 'Bipolar and Related Disorders'}, {'id': 'D019964', 'term': 'Mood Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D003866', 'term': 'Depressive Disorder'}, {'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C046649', 'term': 'ropinirole'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'count': 60}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2003-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2006-06', 'lastUpdateSubmitDate': '2006-06-08', 'studyFirstSubmitDate': '2006-06-08', 'studyFirstSubmitQcDate': '2006-06-08', 'lastUpdatePostDateStruct': {'date': '2006-06-09', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-06-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Hamilton Depression Rating Scale Score'}], 'secondaryOutcomes': [{'measure': 'Montgomery Asberg Depression Rating Scale Score'}]}, 'conditionsModule': {'keywords': ['ropinirole', 'dopamine', 'D2', 'depression', 'bipolar'], 'conditions': ['Bipolar Disorder', 'Major Depressive Disorder']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* DSM-IV Major Depression OR Bipolar I or II Disorder - Currently Depressed\n* One month of a stable, adequate dose of antidepressant medication\n* Bipolar patients must have a mood stabilizer\n* At least 18 years old\n* Modified HDRS-21 more than 16 (Scores reverse vegetative symptoms.)\n* Informed Consent\n\nExclusion Criteria:\n\n* CVA\n* Antipsychotic Medication\n* Drug or Alcohol Abuse\n* Active Suicidality\n* Rapid Cycling Bipolar Disorder\n* Neurologic or Dementing Illness\n* Psychosis\n* Parkinsonism\n* Pregnancy'}, 'identificationModule': {'nctId': 'NCT00335205', 'briefTitle': 'A Placebo Controlled Trial of the Dopamine D-2 Receptor Agonist Ropinirole in Treatment of 60 Patients With Refractory Bipolar Depression.', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Sheba Medical Center'}, 'officialTitle': 'A Placebo Controlled Trial of the Dopamine D-2 Receptor Agonist Ropinirole in Treatment of 60 Patients With Refractory Bipolar I and II Depression.', 'orgStudyIdInfo': {'id': 'SHEBA-02-2690-LG-CTIL'}}, 'armsInterventionsModule': {'interventions': [{'name': 'ropinirole', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Jerusalem', 'status': 'ACTIVE_NOT_RECRUITING', 'country': 'Israel', 'facility': 'Jerusalem Mental Health Center', 'geoPoint': {'lat': 31.76904, 'lon': 35.21633}}, {'zip': '52621', 'city': 'Tel Litwinsky', 'status': 'RECRUITING', 'country': 'Israel', 'contacts': [{'name': 'Ari A Gershon, MD', 'role': 'CONTACT', 'email': 'agershon@sheba.health.gov.il', 'phone': '+972-3-5349105'}], 'facility': 'Chaim Sheba Medical Center, Dept. of Psychiatry', 'geoPoint': {'lat': 32.05096, 'lon': 34.84588}}], 'centralContacts': [{'name': 'Ari A Gershon, MD', 'role': 'CONTACT', 'email': 'agershon@sheba.health.gov.il', 'phone': '+972-3-5349105'}], 'overallOfficials': [{'name': 'Leon Grunhaus, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Jerusalem Mental Health Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sheba Medical Center', 'class': 'OTHER_GOV'}, 'collaborators': [{'name': 'Jerusalem Mental Health Center', 'class': 'OTHER_GOV'}]}}}