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

Ewha Womans University

Status and phase

Withdrawn

Phase 2

Conditions

Major Depressive Disorder

Treatments

Drug: Quetiapine Fumarate Extended Release

Study type

Interventional

Funder types

Other

Identifiers

NCT01189318

D1443C00042

Details and patient eligibility

About

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.

Sex

All

Ages

20 to 65 years old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion 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