Major Depressive Disorder With Psychotic Features Clinical Trial
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
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 Reuptake Inhibitor.
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.
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| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT04324944 -
Adapting and Examining Collaborative Decision Skills Training Among Veterans With Serious Mental Illness
|
N/A | |
| Completed |
NCT00056472 -
Study of Pharmacotherapy of Psychotic Depression
|
Phase 3 |