Effects of Seroquel XR on Sleep Architecture in Patients With Major Depressive Disorder

Study Overview
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Brief Summary
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In this study, patients with major depressive disorder (MDD) who have insomnia symptom are treated with Seroquel XR in an open-label manner for a 4-week period with repeated measurements of insomnia symptoms and sleep parameters using polysomnography.

Official Title
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Effects of Seroquel XR (Quetiapine Fumarate Extended-Release) on Sleep Architecture in Patients With Major Depressive Disorder

Conditions
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Major Depressive Disorder

Intervention / Treatment
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* Drug: Quetiapine Fumarate Extended Release


Participation Criteria
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Eligibility Criteria
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Patient Inclusion Criteria: Men and women aged between 20 and 65 Diagnosis of major depressive disorder as assessed by Structured Clinical Interview for DSM-IV (SCID-IV) A score of 1 or greater on any of the sleep items (items 4, 5, 6) from the Hamilton Depression Rating Scale (HDRS) Provision of written informed consent Healthy Control Subject Inclusion Criteria: Healthy Men and Women aged between 20 and 65 Provision of written informed consent Exclusion Criteria: Presence of any major physical or neurological illness (e.g.，head trauma， epilepsy，seizure，stroke，cerebral tumor，multiple sclerosis，cerebrovascular disease, narrow-angle glaucoma, drug hypersensitivity，etc.) Diagnosis of any Axis I disorder other than major depressive disorder or presence of symptoms requiring hospitalization Drug abuse in past 3 months Women who are pregnant，breastfeeding, or planning pregnancy Contraindications to drugs used in the study (e.g., allergy, intolerance, etc.) Unstable medical illness or severe abnormality in laboratory test at screening assessment Increase in blood glucose, lipid, and calcium levels at screening Low blood pressure at screening assessment Intelligence quotient below 80 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 3A4 inducers in the 14 days preceding enrolment 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 randomisation Substance or alcohol dependence at enrolment (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 3 months prior to enrolment Previous enrolment or randomisation of treatment in the present study. Participation in another drug trial within 4 weeks prior enrolment into this study or longer in accordance with local requirements Medical conditions that would affect absorption, distribution, metabolism, or excretion of study treatment A patient with Diabetes Mellitus An absolute neutrophil count (ANC) of <= 1.5 x 10^9 per liter Insomnia from other causes of medical or neurological diseases Involvement in the planning and conduct of the study

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Seroquel XR<br>Patients with MDD receives Seroquel XR. | Drug: Quetiapine Fumarate Extended Release<br>* Day 1 50mg, Day 2 50mg, Day 3 150mg, Day 4 28 50 150mg (increments and deduction of 50mg are allowed)<br>|
| No Intervention: healthy control<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change from baseline Pittsburgh Quality Index total scores at 4 weeks |  | baseline and 4 weeks | 
| change from baseline Pittsburgh Quality Index total scores at 2 weeks |  | baseline and 2 weeks | 
| change from baseline Pittsburgh Quality Index total scores at 4 days |  | baseline and 4 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change from baseline in sleep architecture measured using polysomnography at 4 weeks |  | baseline and at 4 weeks | 
| number of participants with adverse events |  | 4 weeks | 
| number of participants with adverse events |  | 2 weeks | 
| number of participants with adverse events |  | 4 days |