Patients with Bipolar affective disorder
Conditions
Interventions
Product Name: Quetiapin
Pharmaceutical Form: Tablet
INN or Proposed INN: Quetiapinhemiflurat
Current Sponsor code: L1449LOOO27
Concentration unit: mg milligram(s)
Concentration type: equal
Concentrati
Sponsors
Otto-von-Guericke University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Provision of written informed consent 2. A diagnosis of depression in BP by Diagnostic and Statistical Manual of Mental Disorders- Fourth Edition (DSM-IV) 3. Females and males aged between 18 and 60 years 4. Able to understand and comply with the requirements of the study 5. HAM-D > 20 6. Presence of affective and cognitive symptoms according to HAM-D and MADRAS Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Pregnancy or lactation 2. Any DSM-IV Axis I disorder not defined in the inclusion criteria 3. Patients who, in the opinion of the investigator, pose an imminent risk of suicide or a danger to self or others 4. Known intolerance or lack of response to quetiapine fumarate, as judged by the investigator 5. 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 6. 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 7. Administration of a depot antipsychotic injection within one dosing interval (for the depot) before randomisation 8. Substance or alcohol dependence at enrolment (except dependence in full remission, and except for caffeine or nicotine dependence), as defined by DSM-IV criteria 9. Opiates, amphetamine, barbiturate, cocaine, cannabis, or hallucinogen abuse by DSM-IV criteria within 4 weeks prior to enrolment 10. Medical conditions that would affect absorption, distribution, metabolism, or excretion of study treatment 11. Unstable or inadequately treated medical illness (e.g. diabetes, angina pectoris, hypertension) as judged by the investigator 12. Involvement in the planning and conduct of the study 13. Previous enrolment or randomisation of treatment in the present study. 14. Participation in another drug trial within 4 weeks prior enrolment into this study or longer in accordance with local requirements 15. Treatment with other neuroleptics or other psychotropic drugs (beta blocker, etc.) 16. Diagnosis of organic depression, Dementia, or Anxiety Disorder (according to DSM IV)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Secondary Objective: Depressed patients shall include both those with and without predominant cognitive symptoms. Neuroanatomical and metabloic distinction between bipolar patients with and without cognitive symptoms.;Main Objective: The general aim is the investigation of the functional neuroanatomy and regional metabolism in patients with depression in bipolar patients before and after treatment with quetiapin. Using a 7 Tesla scanner, functional subcortical-cortical neuroanatomy will be revealed in functional magnetic resonance imaging (fMRI) whereas regional metabolism will be investigated with magnetoresonancespectroscopy (MRS).;Primary end point(s): The endppoints are neuroanatomical and metabolic markers for therapeutic response to quetiapin after 6 weeks of treatment in bipolar disorder | — |
Countries
Germany
Outcome results
None listed