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

Phase 2

Withdrawn

• Conditions: Major Depressive Disorder
• Interventions: Drug: Quetiapine Fumarate Extended Release

• Registration Number: NCT01189318
• Lead Sponsor: Ewha Womans University

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-08-17
• Study First Submitted QC: 2010-08-25
• Study First Posted: 2010-08-26
• Study Start: 2012-03
• Primary Completion: 2014-02
• Study Completion: 2014-02
• Status Verified: 2015-08
• Last Update Submitted: 2015-08-05
• Last Update Posted: 2015-08-07

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Seroquel XR	Quetiapine Fumarate Extended Release	Patients with MDD receives Seroquel XR.

Primary Outcome Measures

Name	Time	Method
change from baseline Pittsburgh Quality Index total scores at 4 days	baseline and 4 days
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

Secondary Outcome Measures

Name	Time	Method
change from baseline in sleep architecture measured using polysomnography at 4 weeks	baseline and at 4 weeks
number of participants with adverse events	4 days

Trial Locations

Locations (1)

Ewha Womans University Medical Center; 🇰🇷 Seoul, Korea, Republic of