Acutely Manic Patients Insufficiently Responding After 2 Weeks Continued Quetiapine Monotherapy: Continued Quetiapine Versus Sodium Valproate Add-on.

• Conditions: Bipolar affective disorder

• Registration Number: EUCTR2005-000211-99-DK
• Lead Sponsor: AstraZeneca A/S

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2005-02-11
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 0

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

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified