An open-label, non-comparative, multi-centre, phase II prospective trial to assess the efficacy of Quetiapine fumarate augmentation of selective serotonin reuptake inhibitors (SSRIs) in SSRI-resistant major depressive disorder.
- Conditions
- 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: 8.0Classification code 10025453
- Registration Number
- EUCTR2005-001737-15-BE
- Lead Sponsor
- V AstraZeneca SA
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 40
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
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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method