Status:
TERMINATED
Seroquel Alone Versus Seroquel With an SSRI for Depression With Psychotic Symptoms
Lead Sponsor:
Massachusetts General Hospital
Conditions:
Major Depressive Disorder With Psychotic Features
Eligibility:
All Genders
18-85 years
Phase:
PHASE4
Brief Summary
The purpose of this study is to compare the efficacy and tolerability of Seroquel monotherapy for the treatment of Major Depression with Psychotic features with Seroquel plus Selective Serotonin Reupt...
Detailed Description
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 ...
Eligibility Criteria
Inclusion
- Written informed consent
- Diagnosis of Major Depressive Disorder with Psychotic Features by the DSM-IV
- Females and Males between the ages of 18-85 years.
- 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
- Able to understand and comply with the requirements of the study
- Initial HAM-D-17 score of \> 16, both at the screen visit and at the baseline visit.
- 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.
- Participants must have an initial CGI score of \> 2, both at the screen visit and at the baseline visit.
Exclusion
- Pregnancy or lactation
- Any DSM-IV Axis I disorder not defined in the inclusion criteria
- Patients who, in the opinion of the investigator, pose an imminent risk of suicide or a danger to self or others
- Known intolerance or lack of response to quetiapine fumarate, as judged by the investigator
- 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
- 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
- Administration of a depot antipsychotic injection within one dosing interval (for the depot) before randomization
- 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
- Opiates, amphetamine, barbiturate, cocaine, cannabis, or hallucinogen abuse by DSM-IV criteria within 4 weeks prior to enrolment
- Medical conditions that would affect absorption, distribution, metabolism, or excretion of study treatment
- Unstable or inadequately treated medical illness (e.g. diabetes, angina pectoris, hypertension) as judged by the investigator
- Involvement in the planning and conduct of the study
- Previous enrolment or randomization of treatment in the present study.
- Participation in another drug trial within 4 weeks prior enrollment into this study or longer in accordance with local requirements
- 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
- An absolute neutrophil count (ANC) of 1.5 x 10\^9 per liter
- 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.
- Patients who are currently treated with antidepressants other than the selective serotonin reuptake inhibitors, with mood stabilizing or antipsychotic drugs other than quetiapine.
- Patients with known arrhythmias or arrhythmias noted on screening EKG.
- Outpatients with a CGI score of 7.
Key Trial Info
Start Date :
September 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2013
Estimated Enrollment :
32 Patients enrolled
Trial Details
Trial ID
NCT00955474
Start Date
September 1 2008
End Date
January 1 2013
Last Update
April 20 2017
Active Locations (1)
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1
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114