europrotective Properties of Quetiapine versus Lithium in a First Episode Mania Cohort: 12-month Neuroanatomical, Neurochemical and Neuro-cognitive Effects and Preliminary Data of Prophylactic Properties
- Conditions
- First episode mania (bipolar and schizoaffective illnesses)Mental Health - Other mental health disorders
- Registration Number
- ACTRN12607000639426
- Lead Sponsor
- The University of Melbourne
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 61
Meet Diagnostic and Statistical Manual IV Text Revised (DSM-IV TR) diagnosis for mania as part of bipolar I disorder or schizoaffective disorder. Have a Young Mania Rating Scale at baseline of at least 20. Not have had a previous treated manic episode. Have the capacity to provide informed consent to the study and comply with study procedures. Be utilising effective contraception if female, sexually active and of childbearing age. Patients will need to have been on quetiapine and lithium as standard therapy for at least 1 month prior to randomisation.
Exclusion from the trial includes:
-Patients with a known or suspected clinically relevant systemic medical disorder.
-Individuals who are pregnant or lactating.
-Patients who have had a prior sensitivity or allergy to quetiapine, lithium or their components.
-Inability to comply with either the requirements of informed consent or the treatment protocol.
-Non-fluency in English.
-History of epilepsy.
-Clinically relevant biochemical or haematological abnormalities at baseline.
-Patients at immediate risk of self harm or risk to others.
-Organic mental disease, including mental retardation (Full scale IQ<70).
-Use of any of the following cytochrome P450 3A4 inhibitors in the 14 days preceding enrolment including but not limited to: ketoconazole, itraconazole, fluconazole, erythromycin, clarithromycin, troleandomycin, indinavir, nelfinavir, ritonavir, fluvoxamine and saquinavir
-Use of any of the following cytochrome P450 inducers in the 14 days preceding enrollment including but not limited to: phenytoin, carbamazepine, barbiturates, rifampin, St. John’s Wort, and glucocorticoids
-A patient with Diabetes Mellitus (DM) fulfilling one of the following criteria:
•Unstable DM defined as enrollment glycosylated hemoglobin (HbA1c) >8.5%.
•Admitted to hospital for treatment of DM or DM related illness in past 12 weeks.
•Not under physician care for DM
•Physician responsible for patient’s DM care has not indicated that patient’s DM is controlled.
•Physician responsible for patient’s DM care has not approved patient’s participation in the study
•Has not been on the same dose of oral hypoglycaemic drug(s) and/or diet for the 4 weeks prior to randomization. For thiazolidinediones (glitazones) this period should not be less than 8 Weeks.
•Taking insulin whose daily dose on one occasion in the past 4 weeks has been more than 10% above or below their mean dose in the preceding 4 weeks
Note: If a diabetic patient meets one of these criteria, the patient is to be excluded even if the treating physician believes that the patient is stable and can participate in the study.
-An absolute neutrophil count (ANC) of 1.5 x 109 per liter
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method euroanatomical changes as measured through Magnetic Resonance Imaging (MRI) comparisons.[Baseline (manic episode stabilisation), three months and 12 months.]
- Secondary Outcome Measures
Name Time Method europsychological changes across the study period will be assessed and correlated with neuroanatomical changes as will symptomatic and functional recovery.[Baseline (manic episode stabilisation), two weeks, four weeks, eight weeks, three]