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

Major Depressive Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01189318
• Other study ID #: D1443C00042
• Status: Withdrawn
• Phase: Phase 2
• First received: August 17, 2010
• Last updated: August 5, 2015
• Start date: March 2012
• Est. completion date: February 2014

Study information

• Verified date: August 2015
• Source: Ewha Womans University
• Contact: n/a
• Is FDA regulated: No
• Health authority: South Korea: Korea Food and Drug Administration (KFDA)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: February 2014
• Est. primary completion date: February 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 20 Years to 65 Years

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Major
• Major Depressive Disorder

Intervention

Drug:
• Quetiapine Fumarate Extended Release
Day 1 50mg, Day 2 50mg, Day 3 150mg, Day 4~28 50~150mg (increments and deduction of 50mg are allowed)

Locations

Country	Name	City	State
Korea, Republic of	Ewha Womans University Medical Center	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Ewha Womans University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	change from baseline Pittsburgh Quality Index total scores at 4 weeks		baseline and 4 weeks	No
Primary	change from baseline Pittsburgh Quality Index total scores at 2 weeks		baseline and 2 weeks	No
Primary	change from baseline Pittsburgh Quality Index total scores at 4 days		baseline and 4 days	No
Secondary	change from baseline in sleep architecture measured using polysomnography at 4 weeks		baseline and at 4 weeks	No
Secondary	number of participants with adverse events		4 weeks	Yes
Secondary	number of participants with adverse events		2 weeks	Yes
Secondary	number of participants with adverse events		4 days	Yes