Status:
WITHDRAWN
Effects of Seroquel XR on Sleep Architecture in Patients With Major Depressive Disorder
Lead Sponsor:
Ewha Womans University
Conditions:
Major Depressive Disorder
Eligibility:
All Genders
20-65 years
Phase:
PHASE2
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 s...
Eligibility Criteria
Inclusion
- Patient
- 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
- Healthy Men and Women aged between 20 and 65
- Provision of written informed consent
Exclusion
- 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
Key Trial Info
Start Date :
March 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2014
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT01189318
Start Date
March 1 2012
End Date
February 1 2014
Last Update
August 7 2015
Active Locations (1)
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1
Ewha Womans University Medical Center
Seoul, South Korea