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| Sponsor: | Massachusetts General Hospital |
|---|---|
| Information provided by: | Massachusetts General Hospital |
| ClinicalTrials.gov Identifier: | NCT00955474 |
Purpose
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 Seratonin Reuptake Inhibitor.
| Condition | Intervention | Phase |
|---|---|---|
|
Major Depressive Disorder With Psychotic Features |
Drug: Quetiapine monotherapy Drug: Quetiapine with SSRI |
Phase IV |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Single Blind (Outcomes Assessor), Parallel Assignment, Efficacy Study |
| Official Title: | The 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 |
| Estimated Enrollment: | 80 |
| Study Start Date: | September 2008 |
| Estimated Study Completion Date: | January 2012 |
| Estimated Primary Completion Date: | January 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Quetiapine monotherapy: Experimental
Patients assigned to receive Seroquel monotherapy
|
Drug: Quetiapine monotherapy
• Quetiapine XR 100 mg/h.s. will be the starting dose and increased by 100 mg q h.s. q day to a target dose of 300 mg/h.s. by day three and continued on 300 mg/h.s. through week three. Between weeks four and eight, there will be flexible dosing up to 800 mg/h.s. or reductions in doses to no lower than 200 mg/h.s. Incremental increases or decreases in dose will be no more than 100 mg/h.s. over a minimum of one week, unless a patient is unable to tolerate the current dose. Patients unable to tolerate at least 200 mg/h.s. will be discontinued from the study.
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|
Quetiapine with SSRI: Active Comparator
Patients assigned to receive both Seroquel and an SSRI
|
Drug: Quetiapine with SSRI
|
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.
Eligibility| Ages Eligible for Study: | 18 Years to 85 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
A patient with Diabetes Mellitus (DM) fulfilling one of the following criteria:
Contacts and Locations| Contact: Rita Seabrook | 617-724-9142 | |
| Contact: Lauren House | 617-724-9141 |
| United States, Massachusetts | |
| Massachusetts General Hospital | Recruiting |
| Boston, Massachusetts, United States, 02114 | |
| Contact: Rita 617-724-9142 | |
| Principal Investigator: | John Matthews, MD | Massachusetts General Hospital |
More Information
| Responsible Party: | Massachusetts General Hospital ( John Matthews, MD ) |
| Study ID Numbers: | 2008P001022 |
| Study First Received: | August 6, 2009 |
| Last Updated: | January 13, 2010 |
| ClinicalTrials.gov Identifier: | NCT00955474 History of Changes |
| Health Authority: | United States: Institutional Review Board |
|
Neurotransmitter Uptake Inhibitors Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Psychotropic Drugs Depressive Disorder, Major Pathologic Processes Mental Disorders Therapeutic Uses Psychotic Disorders Antidepressive Agents, Second-Generation Schizophrenia and Disorders with Psychotic Features Antidepressive Agents Tranquilizing Agents |
Disease Depression Central Nervous System Depressants Depressive Disorder Antipsychotic Agents Serotonin Uptake Inhibitors Citalopram Pharmacologic Actions Behavioral Symptoms Quetiapine Serotonin Agents Mood Disorders Central Nervous System Agents |