Bipolar affective disorder
Conditions
Interventions
Product Name: Seroquel
Pharmaceutical Form: Tablet
INN or Proposed INN: quetiapine fumerate
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 100-200
Product Name: O
Sponsors
AstraZeneca A/S
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: For inclusion in the study subjects must fulfil all of the following criteria: 1. Men and woman, age = 18 years. 2. Suffer from a manic or mixed episode according to the DSM IV criteria (Bech-Rafaelsen Mania Rating Scale (MAS) score should be = 15). 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) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Any of the following is regarded as a criterion for exclusion from the study: 1. Patients who have not provided personal informed consent. 2. Known intolerance, hypersensitivity or lack of anti manic response to sodium valproate or quetiapine fumarate. 3. Pregnancy and lactation. Female subjects of childbearing potential must have a negative serum human chorionic gonadotropine (HCG) test and must maintain effective (reliable) contraception during the study period. Effective contraception is regarded as surgical sterilisation, intrauterine device or hormonal contraception. 4. Substance or alcohol dependence at enrolment likely to interfere with the protocol, inclusive evaluation of mania. 5. Use of any of the following cytochrome P450 inhibitors in the 14 days preceding enrolment, including but not limited to: ketoconazole, itraconazole, fluconazole, erythromycin, clarithromycin, indinavir, nelfinavir, ritonavir and saquinavir. 6. Use of any of the following cytochrome P450 inducers in the 14 days preceding enrolment, including but not limited to: phenytoin, carbamazepine, barbiturates, rifampin and glucocorticoider. 7. Any significant past or current disease or disorder which, in the opinion of the investigator, may either put the subject at risk in the study, influence the results of the study or influence the subject’s ability to participate in the study, especially: - cardiovascular disorders - cerebrovascular disorders - conditions associated with hypotension - coagulation disorders - endocrinological disease - hepatic disease - renal impairment Elderly subjects with dementia-related psychosis (elderly defines as 65 years old or older) are considered at increased risk and must not be included into the study 8. Medical conditions that would affect absorption, distribution, metabolism or excretion of the study drugs. 9. Use of study drugs within one week prior to the inclusion. 10. Prophylactic lithium treatment that have lasted less than 3 months and dose adjustments in lithium treatment within 1 month. 11. Lamotrigine treatment that have lasted less than 3 months. 12. Involvement in the planning and conduct of the study (applies to both AstraZeneca staff or staff at the investigational site). 13. Previous inclusion into the present study. 14. Involuntary admittance / detainment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective is to investigate whether the addition of sodium valproate will be superior to treatment with quetiapine given as mono-therapy for an additional 14 days in non-responding patients after a 14 days initial treatment period with quetiapine.;Primary end point(s): The number of responders in the two treatment groups (quetiapine + sodium valproate placebo / quetiapine + sodium valproate).;Secondary Objective: To evaluate the proportion of responders to quetiapine administered as = 800 mg daily in 8 days preceded by a titration period of 6 days. To assess the magnitude of the response by analysing the MAS score as a continuous variable. To assess the magnitude of the response by analysing the MES score as a continuous variable. To evaluate the patient’s global mental condition by CGI score measured as a continuary variable. To evaluate the number of subjects in remission following quetiapine treatment administered as = 800 mg daily in 8 days preceded by a titration period of 6 days. To compare the numbers of subjects in remission in the two treatment groups after the double-blind treatment period. To assess the number of in hospital days and ambulant visits beyond the scheduled visits. To compare the tolerability of the two treatments given after the last treatment period of 14 days. | — |
Countries
Denmark
Outcome results
None listed