Maintenance treatment of patients with Major Depressive Disorder
Conditions
Sponsors
AstraZeneca AB
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Provision of written informed consent before initiation of any study- related procedures. 2. Men and women aged 18 to 65 years. 3. A documented clinical diagnosis according to the DSM-IV (Diagnostic and Statistical Manual of Mental Disorders, 4th edition) meeting criteria 296.2x Major Depressive Disorder, Single Episode, or 296.3x Major Depressive Disorder, Recurrent. 4. HAM-D(17-item) total score of =20 and HAM-D-17 item 1 (depressed mood) score of =2 at enrolment. 5. Female patients of childbearing potential must have a negative serum pregnancy test at enrolment and be willing to use a reliable method of birth control, i.e. barrier method, oral contraceptive, implant, dermal contraception, long-term injectable contraceptive, intrauterine device or tubal ligation, during the study. 6. Be able to understand and comply with the requirements of the study, as judged by the investigator. 7. Outpatient status at enrolment. 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 DSM-IV Axis I disorder other than MDD within 6 months of enrolment. 2. Patients with a diagnosis of DSM-IV Axis II disorder which has a major impact on the patient's current pschiatric status. 3. Patients whose current episode of depression exceeds 12 months or is less than 4 weeks from enrolment. 4. History of inadequate response to an adequate treatment (6 weeks) with 2 or more classes of antidepressants during current depressive episode. 5. Substance or alcohol abuse or dependence within 6 months prior to enrolment (except dependence in full remission, and except for caffeine or nicotine dependence), as defined in DSM-IV criteria. 6. Use of drugs that induce or inhibit the hepatic metabolising cytochrome 3A4 enzymes within 14 days prior to the Open-label Run-in Treatment Period (Visit 2). 7. Evidence of clinically relevant disease (e.g. renal or hepatic impairment, significant coronary artery disease, cerebrovascular disease, viral hepatitis B or C, acquired immunodeficiency syndrome [AIDS]), or a clinical finding that is unstable or that, in the opinion of the investigator, would be negatively affected by the study medication or that would affect the study medication. 8. A current diagnosis of cancer, unless in remission (except basal or squamous cell skin carcinoma). 9. Current or past diagnosis of stroke or Transient Ischemic Attacks (TIA). 10. History of seizure disorder, except febrile convulsions. 11. Receipt of electroconvulsive therapy (ECT) within 28 days prior to enrolment. 12. Use of antipsychotic, mood stabiliser, anticonvulsant or antidepressant drugs within 7 days before Open-label Run-in Treatment. 13. Patients who, in the investigators opinion will require psychotherapy (other than supportive psychotherapy) during the study period, unless psychotherapy has been ongoing for a minimum of 3 months prior to enrolment. 14. Patients who, in the investigator’s judgment, pose a current serious suicidal or homicidal risk, have a HAM-D-17 item 3 score of 3 or greater, or have made a suicide attempt within the past 6 months. 15. A patient with Diabetes Mellitus (DM) fulfiling one of the following criteria. 16. Clinically significant deviation from the reference range in clinical laboratory test results as judged by the investigator. 17. An ANC (absolute neutrophil count) of less than 1.5 x 109 per liter. 18. A thyroid-stimulating hormone (TSH) concentration more than 10% above the upper limit of the normal range of the laboratory used for sample analysis at enrolment, whether or not the patient is being treated for hypothyroidism. 19. ECG results considered clinically significant as determined by the investigator based on assessment by a centrally located experienced cardiologist interpreting the ECG. 20. Known history of intolerance or hypersensitivity to quetiapine or to any other component in the tablet.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of the study is to evaluate the efficacy of quetiapine SR compared to placebo in increasing time from randomisation to a depressed event in patients with Major Depressive Disorder (MDD).; Secondary Objective: 1. To evaluate the effect of quetiapine SR compared to placebo on health-related quality of life in patients with MDD during long-term treatment. 2. To evaluate the efficacy of quetiapine SR compared to placebo in maintaining improvement of depressive symptoms in patients with MDD during long-term treatment. 3. To evaluate the effect of quetiapine SR compared to placebo on anxiety symptoms in patients with MDD during long-term treatment. 4. To evaluate the effect of quetiapine SR compared to placebo on quality of sleep in patients with MDD during long-term treatment. 5. To evaluate the effect of quetiapine SR compared to placebo on suicidal ideation in patients with MDD during long-term treatment. 6. To evaluate the effect of quetiapine SR compared to placebo on functional disability in patients with MDD during long-term treatment. 7. To evaluate whether quetiapine SR compared to placebo is safe and well-tolerated in patients with MDD during long-term treatment. ;Primary end point(s): The primary objective of the study is to evaluate the efficacy of quetiapine SR compared to placebo in increasing time from randomisation to a depressed event in patients with MDD. A depressed event is defined as fulfilling at least one of the following: (a) Initiation of pharmacological treatment by the investigator, other than the allowed hypnotics, to treat depressive symptoms, (b) Initiation of pharmacological treatment by the patient for at least one week, other than the allowed hypnotics, to treat depressive symptoms, (c) Hospitalisation for depressive symptoms, (d) Montgomery- Åsberg Depression Rating Scale (MADR | — |
Countries
Finland, Germany, Slovakia, United Kingdom
Outcome results
None listed