The medical condition being treated by this protocol is single or recurrent major depressive disorder (MDD), not responding to at least one adequate SSRI treatment, however, the patients being treated should be naïve to any atypical antipsychotic. MedDRA version: 8.0 Classification code 10025453
Conditions
Interventions
Trade Name: Seroquel 100mg
Product Name: Seroquel 100mg
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: quetiapine fumarate
Concentration unit: mg milligram(s)
Concentration type: equal
C
Sponsors
NV AstraZeneca SA
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: For inclusion in the study all of the following criteria must be fulfilled on day 1: 1. Male and female patients, aged between 18 and 65 with a major depressive disorder not responding to at least one acute treatment with a SSRI and naïve to any atypical antipsychotic will be considered for entry into the study. 2. Provision of informed consent before initiating any study-related procedures 3. Female or male aged between 18 and 65 years who can read and write 4. Naïve to any atypical antipsychotic 5. A diagnosis of major depressive disorder, single or recurrent without psychotic features, according to the DSM-IV-R definition 6. Being treated for at least 6 weeks with a daily effective dose of an SSRI e.g. citalopram = 20 mg, escitalopram = 10 mg, fluoxetine = 20 mg, fluvoxamine = 100 mg, paroxetine = 20 mg, sertraline = 50 mg 7. MADRS score = 25 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. Patients with a history of bipolar I or II disorder as defined by DSM-IV-R 2. Diagnosis of psychotic major depression disorder according to the DSM-IV-R criteria 3. Substance of alcohol dependence at enrolment (except for caffeine or nicotine dependence) as defined by DSM-IV-R criteria 4. Opiates, amphetamine, barbiturate, cocaine, cannabis, or hallucinogen abuse by DSM-IV-R criteria 5. No or inadequate response to more than two different SSRIs given at the adequate dose during an adequate period of time 6. Use of any of the following CYP450 3A4 inhibitors in the 14 days preceding enrolment including but not limited to fluvoxamine, ketoconazole, itraconazole, fluconazole, erythromycin, clarithromoycin, troleandeomycin, indinavir, nelfinavir, ritonavir and saquinavir 7. Use of any of the following CYP450 3A4 inducers in the 14 days preceding the enrolment including but not limited to : phenytoin, carbamazepine, barbiturates, rifampin, St. John’s Wort, and flucocorticoids 8. Use of the SSRI fluvoxamine in the 14 days preceding the enrolment 9. Medical conditions that would affect absorption, distribution, metabolism or excretion of study treatment 10. Pregnancy, breast-feeding or planned pregnancy during the study. Fertile women not using a medically acceptable contraceptive. 11. Known or suspected hypersensitivity to the investigational product or excipiens 12. Planned in-patient hospitalization during the course of the study. 13. Any clinically significant abnormal finding at visit 1, which in the opinion of the investigator, may put the patient at risk because of his/her participation in the study. 14. Patients suffering from hyperthyroidism 15. In the opinion of the investigator, the patient is likely to be non-compliant with the study visit schedule or with the study procedures (e.g. illiterate, poor compliance, etc.) 16. Involvement in the planning and the conduct of the study (applies to both AstraZeneca staff or staff at the investigational site) 17. Previous enrolment in the present study. 18. Patients who in the opinion of the investigator, pose an imminent risk of suicide or danger to self or others.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective is to assess the efficacy of Quetiapine fumarate augmentation on the overall depression status of patients with major depressive disorder who don’t respond to at least one acute treatment with a SSRI.;Secondary Objective: The secondary objectives are : - To assess the efficacy of Quetiapine fumarate augmentation on the psychological symptom patterns of patients with major depressive disorder - To assess the efficacy of Quetiapine fumarate augmentation on the functional disability - To assess the efficacy of Quetiapine fumarate augmentation on the global clinical impression of patients with major depressive disorder - To assess the safety and tolerability of Quetiapine fumarate in patients with major depressive disorder ;Primary end point(s): The primary endpoint is to see a general average decrease in MADRS score over 4 weeks of treatment with Quetiapine fumarate. Whereas response is defined as a reduction in MADRS score of 50 % or more and remission is defined as a MADRS score equal to or below 12. | — |
Countries
Belgium
Outcome results
None listed