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

• Status: Withdrawn
• Trial end date: 2014-02-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Ewha Womans University
• Treatments: Quetiapine Fumarate

Criteria

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