SeroquelThe Efficacy and Tolerability of Seroquel XR Combined With a Selective Serotonin Re-Uptake Inhibitor Versus Seroquel XR Monotherapy in the Acute Treatment of Major Depressive Disorder With Psychotic Features
Quetiapine
+ escitalopram
+ Sertraline
Treatment Study
Summary
Study start date: September 1, 2008
Actual date on which the first participant was enrolled.The proposed study is designed to investigate the non-inferiority of treatment of PsyD using monotherapy with quetiapine XR versus combination treatment using quetiapine XR and an SSRI (sertraline or citalopram or escitalopram) during the acute phase of treatment. The primary outcome measures will be the change rates of symptoms of depression (as measured on the Hamilton Rating Scale for Depression \[HAM-D-17\] and psychosis (as measured on the Brief Psychiatric Rating Scale \[BPRS\] Positive Symptoms Subscale). The secondary aim of the study is to assess the safety and efficacy of the combination of quetiapine XR and SSRIs in patients with the diagnosis of PsyD. Metabolic factors including fasting glucose, fasting insulin, and fasting lipids (total cholesterol, HDL, LDL, and triglycerides) will be obtained at screen and at the 8-week endpoint of the study to assess the impact of treatment on the development of risk factors for metabolic syndrome. Measures of cognitive function (MGH Cognitive and Physical Functioning Questionnaire and RBANS) (Fava et al. 2006; Randolph et al. 1998) will be obtained at screen and the 8-week endpoint of the study to assess the impact of treatment on cognitive function.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.32 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.From 18 to 85 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Criteria
Inclusion Criteria: 1. Written informed consent 2. Diagnosis of Major Depressive Disorder with Psychotic Features by the DSM-IV 3. Females and Males between the ages of 18-85 years. 4. Female patients of childbearing potential must be using a reliable method of contraception and have a negative urine human chorionic gonadotropin (HCG) test at enrolment 5. Able to understand and comply with the requirements of the study 6. Initial HAM-D-17 score of \> 16, both at the screen visit and at the baseline visit. 7. Participants must have an initial BPRS score of \> 25 and at least one of the following: \> 5 for item 1, \> 5 for item 5, \> 5 for item 8, \> 4 for item 9, \> 1 for item 10, \> 1 for item 11; these BPRS criteria msut be met both at the screen visit and at the baseline visit. 8. Participants must have an initial CGI score of \> 2, both at the screen visit and at the baseline visit. Exclusion Criteria: 1. Pregnancy or lactation 2. Any DSM-IV Axis I disorder not defined in the inclusion criteria 3. Patients who, in the opinion of the investigator, pose an imminent risk of suicide or a danger to self or others 4. Known intolerance or lack of response to quetiapine fumarate, as judged by the investigator 5. Use of any of the following cytochrome P450 3A4 inhibitors in the 14 days preceding enrolment including but not limited to: ketoconazole, itraconazole, fluconazole, erythromycin, clarithromycin, troleandomycin, indinavir, nelfinavir, ritonavir, fluvoxamine and saquinavir 6. Use of any of the following cytochrome P450 inducers in the 14 days preceding enrollment including but not limited to: phenytoin, carbamazepine, barbiturates, rifampin, St. John's Wort, and glucocorticoids 7. Administration of a depot antipsychotic injection within one dosing interval (for the depot) before randomization 8. Substance or alcohol dependence within the past three months (except dependence in full remission, and except for caffeine or nicotine dependence), as defined by DSM-IV criteria 9. Opiates, amphetamine, barbiturate, cocaine, cannabis, or hallucinogen abuse by DSM-IV criteria within 4 weeks prior to enrolment 10. Medical conditions that would affect absorption, distribution, metabolism, or excretion of study treatment 11. Unstable or inadequately treated medical illness (e.g. diabetes, angina pectoris, hypertension) as judged by the investigator 12. Involvement in the planning and conduct of the study 13. Previous enrolment or randomization of treatment in the present study. 14. Participation in another drug trial within 4 weeks prior enrollment into this study or longer in accordance with local requirements 15. A patient with Diabetes Mellitus (DM) fulfilling one of the following criteria: * Unstable DM defined as enrollment glycosylated hemoglobin (HbA1c) \> 8.5%. * Admitted to hospital for treatment of DM or DM related illness in past 12 weeks. * Not under physician care for DM. * Physician responsible for patient's DM care has not indicated that patient's DM is controlled. * Physician responsible for patient's DM care has not approved patient's participation in the study * Has not been on the same dose of oral hypoglycaemic drug(s) and/or diet for the 4 weeks prior to randomization. For thiazolidinediones (glitazones) this period should not be less than 8 Weeks. * Taking insulin whose daily dose on one occasion in the past 4 weeks has been more than 10% above or below their mean dose in the preceding 4 weeks 16. An absolute neutrophil count (ANC) of 1.5 x 10\^9 per liter 17. Patients with a history seizure disorder; unstable physical disorders (cardiovascular, hepatic, renal, respiratory, endocrine, neurologic, or hematologic); or any physical disorder judged to significantly affect central nervous system function. 18. Patients who are currently treated with antidepressants other than the selective serotonin reuptake inhibitors, with mood stabilizing or antipsychotic drugs other than quetiapine. 19. Patients with known arrhythmias or arrhythmias noted on screening EKG. 20. Outpatients with a CGI score of 7.
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.2 intervention groups are designated in this study
This study does not include a placebo group
Treatment Groups
Group I
ExperimentalGroup II
Active ComparatorStudy Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location
Massachusetts General Hospital
Boston, United StatesOpen Massachusetts General Hospital in Google Maps