Ignite Creation Date:
2025-12-25 @ 1:04 AM
Ignite Modification Date:
2026-02-28 @ 8:51 PM
Study NCT ID:
NCT04113993
Status:
RECRUITING
Last Update Posted:
2023-11-28
First Post:
2019-06-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Bazedoxifene -Treatment for Women With Schizophrenia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012559', 'term': 'Schizophrenia'}, {'id': 'D011618', 'term': 'Psychotic Disorders'}], 'ancestors': [{'id': 'D019967', 'term': 'Schizophrenia Spectrum and Other Psychotic Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C447119', 'term': 'bazedoxifene'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'Participants will be randomised to receive either activie treatment or identically packaged placebo'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'This randomized, double-blind, placebo-controlled, 12-week trial will be conducted at two sites- the lead site is the Monash Alfred Psychiatry research Centre in Melbourne (Investigator - Prof Jayashri KULKARNI) , and a second site in Melbourne - The Monash Medical Centre (Investigator - Prof Suresh Sundram). The trial will follow the parallel comparison design consisting of two arms over 12 weeks (treatment x time). Participants will be screened to ensure inclusion / exclusion criteria are met.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 160}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2019-10-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-11', 'completionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-11-26', 'studyFirstSubmitDate': '2019-06-26', 'studyFirstSubmitQcDate': '2019-10-01', 'lastUpdatePostDateStruct': {'date': '2023-11-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-10-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Schizophrenia symptoms', 'timeFrame': '12 Weeks', 'description': 'Symptoms of schizophrenia as measured on the Positive and Negative Symptom Scale (PANSS).\n\nSubscales: Positive, Negative, General Psychopathology.\n\nPositive scale: 7 Items, (minimum score = 7, maximum score = 49). Negative scale: 7 Items, (minimum score = 7, maximum score = 49). General Psychopathology scale:16 Items, (minimum score = 16, maximum score = 112).\n\nPANSS Total score (summed from subscales): minimum = 30, maximum = 210\n\nFor all items, higher values indicate increased symptom severity.'}], 'secondaryOutcomes': [{'measure': 'Cognition', 'timeFrame': '12 Weeks', 'description': 'The neuropsychological battery will include subtests from the following batteries:\n\nMATRICS Consensus Cognitive Battery (MCCB) comprises 7 domains: speed of processing, attention/vigilance, working memory, verbal learning, visual learning, reasoning and problem solving and social cognition.\n\nThe Repeatable Battery for Neuropsychological Status (RBANS) comprises 12 subtests that are used to calculate five index scores (Immediate Memory; Visuospatial/Constructional; Language; Attention and Delayed Memory) and a total score.\n\nA verbal fluency task (Controlled Oral Word Association Task; COWAT), visual attention task (Trails A and B) and measures of premorbid intellect (Test of Premorbid Functioning; TOPF) will also be included.\n\nEye tracking will be an optional extra and will be recorded using The EyeLink (SR Research Ltd). Participants will fixate and/or shift their gaze in response to a number of stimuli, appearing on the screen, as requested by the assessor.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Schizophrenia', 'Schizophreniform Disorders', 'Schizo Affective Disorder']}, 'descriptionModule': {'briefSummary': 'To study the effect of adjunctive bazedoxifene - a selective estrogen receptor modulator (SERM) in a double blind, placebo-controlled adjunctive study in the treatment of women with schizophrenia. All patients receive standardized antipsychotic medication.', 'detailedDescription': "Despite advances in the treatment of schizophrenia, pharmacotherapy remains sub- optimal, and the prognosis for many patients is poor. We have pioneered work showing that estradiol has a positive role in the treatment of psychosis symptoms and cognitive deficits seen in people with schizophrenia. However, with the longer-term work from studies such as the Women's Health Initiative (1), it has become clear that long-term use of estradiol with progesterone may have associated increased risks of breast and other cancers. Hence, we began working with the Selective Estrogen Receptor Modulator - raloxifene, which appears to be safer for longer term use with respect to the development of breast and other cancers. Building on our and others work, raloxifene used as an adjunctive treatment in schizophrenia appears to produce inconsistent and varying responses in different sub-populations; gender, menopausal status, age, drug dose and delivery mode. We now propose to conduct a double-blind, randomized, placebo controlled trial of a third generation SERM - bazedoxifene - which is 4 times more selective for the alpha than the beta oestrogen receptor subtype. Bazedoxifene appears to be safer with respect to long term use than older SERMs, has additional actions on the glucocorticoid receptor, and together this different pharmacology speculatively has greater potential than other SERMs to impact favorably on both psychosis symptoms and cognition in men and women with schizophrenia. This study will test 160 women to determine if bazedoxifene, as an adjunctive hormone modulator, is effective for positive and cognitive symptoms of schizophrenia."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'genderBased': True, 'genderDescription': 'Women', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Physically well.\n* A current DSM-V diagnosis of schizophrenia or related disorder.\n* 18- 65 years\n* Able to give informed consent.\n* PANSS total score between 40 and 90 and a score of 4 (moderate) or more on two or more of the following PANSS items: delusions, hallucinatory behaviour, conceptual disorganization or suspiciousness.\n* Documented normal PAP smear and pelvic examination in the preceding two years.\n* Stable psychotropic medication for previous 4 weeks\n* Normal breast ultrasound\n* IQ \\> 70 (as determined by the WAIS IV subtests)\n* English language proficiency (in order to provide informed consent and complete cognitive test battery)\n\nExclusion Criteria:\n\n* Patients with known abnormalities in the hypothalamo-pituitary gonadal axis, thyroid dysfunction, central nervous system tumours, active or past history of a venous thromboembolic event.\n* Patients with a history of severe traumatic brain injury or significant neurological or unstable medical illness such as epilepsy and diabetes or known active cardiac, renal or liver disease; presence of illness causing immobilisation.\n* Patients whose psychotic illness is directly related to illicit substance use or who have a history of substance dependence during the last six months (with the exclusion of caffeine and/or nicotine dependence).\n* Women aged 40 or over who have not had a normal mammogram in the last 24 months\n* Use of any form of estrogen, progestin or androgen as hormonal therapy in preceding 4 weeks including the pill.\n* Pregnant (HCG will be measured at screening)\n* Breastfeeding\n* Planned changes to psychotropic medication or psychotherapy regimen.'}, 'identificationModule': {'nctId': 'NCT04113993', 'briefTitle': 'Bazedoxifene -Treatment for Women With Schizophrenia', 'organization': {'class': 'OTHER', 'fullName': 'The Alfred'}, 'officialTitle': 'Bazedoxifene - A New Selective Estrogen Receptor Modulator Treatment for Women With Schizophrenia: a Double-blind, Randomized, Placebo Controlled Trial', 'orgStudyIdInfo': {'id': 'HREC Reference 47262'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Oral Bazedoxifene', 'description': 'Oral Bazedoxifene dosed at 40 mg daily', 'interventionNames': ['Drug: Bazedoxifene Acetate']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Identically packaged placebo capsule daily', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Bazedoxifene Acetate', 'type': 'DRUG', 'description': 'Oral Bazedoxifene dosed at 40 mg daily for 12 weeks', 'armGroupLabels': ['Oral Bazedoxifene']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Identically packaged placebo capsule daily', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '3004', 'city': 'Melbourne', 'state': 'Victoria', 'status': 'RECRUITING', 'country': 'Australia', 'contacts': [{'name': 'Jayashri Kulkarni, MBBS,MPM,FRANZCP,PhD', 'role': 'CONTACT', 'email': 'j.kulkarni@alfred.org.au', 'phone': '+61 3 9076 6924'}, {'name': 'Anthony deCastella, Dip App Sci, BA, MA', 'role': 'CONTACT', 'email': 'anthony.decastella@monash.edu', 'phone': '+61 3 9076 6554', 'phoneExt': '66554'}, {'name': 'Jayashri Kulkarni, MBBS,MPM,FRANZCP,PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Anthony deCastella, Dip AppSci,BA,MA', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Emorfia Gavrilidis, BAppSci', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Caroline Gurvich, DPsych FCCN MAPS', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Natalie Thomas, PhD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Abdul Hudaib, MBBS', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Monash Alfred Psychiatry Research Centre', 'geoPoint': {'lat': -37.814, 'lon': 144.96332}}], 'centralContacts': [{'name': 'Anthony de Castella, Applied Scince', 'role': 'CONTACT', 'email': 'Anthony.decastella@monash.edu', 'phone': '+61 390766564'}, {'name': 'MAPrc', 'role': 'CONTACT', 'email': 'maprc@monash.edu', 'phone': '+61 390766564'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The Alfred', 'class': 'OTHER'}, 'collaborators': [{'name': 'Monash University', 'class': 'OTHER'}, {'name': 'Monash Health', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director of Monash Alfred Psychiatry research centre', 'investigatorFullName': 'Jayashri Kulkarni, Professor', 'investigatorAffiliation': 'The Alfred'}}}}