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

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ClinicalTrials.gov Identifier: NCT01189318
Recruitment Status : Withdrawn
First Posted : August 26, 2010
Last Update Posted : August 7, 2015
Sponsor:
Information provided by (Responsible Party):
In Kyoon Lyoo, 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.

Condition or disease Intervention/treatment Phase
Major Depressive Disorder Drug: Quetiapine Fumarate Extended Release Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effects of Seroquel XR (Quetiapine Fumarate Extended-Release) on Sleep Architecture in Patients With Major Depressive Disorder
Study Start Date : March 2012
Actual Primary Completion Date : February 2014
Actual Study Completion Date : February 2014

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Seroquel XR
Patients with MDD receives Seroquel XR.
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)

No Intervention: healthy control



Primary Outcome Measures :
  1. change from baseline Pittsburgh Quality Index total scores at 4 weeks [ Time Frame: baseline and 4 weeks ]
  2. change from baseline Pittsburgh Quality Index total scores at 2 weeks [ Time Frame: baseline and 2 weeks ]
  3. change from baseline Pittsburgh Quality Index total scores at 4 days [ Time Frame: baseline and 4 days ]

Secondary Outcome Measures :
  1. change from baseline in sleep architecture measured using polysomnography at 4 weeks [ Time Frame: baseline and at 4 weeks ]
  2. number of participants with adverse events [ Time Frame: 4 weeks ]
  3. number of participants with adverse events [ Time Frame: 2 weeks ]
  4. number of participants with adverse events [ Time Frame: 4 days ]


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Ages Eligible for Study:   20 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01189318


Locations
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Korea, Republic of
Ewha Womans University Medical Center
Seoul, Korea, Republic of
Sponsors and Collaborators
Ewha Womans University
Investigators
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Principal Investigator: Inkyoon Lyoo, MD, PhD, MMS Ewha Womans University

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Responsible Party: In Kyoon Lyoo, Professor, Ewha Womans University
ClinicalTrials.gov Identifier: NCT01189318     History of Changes
Other Study ID Numbers: D1443C00042
First Posted: August 26, 2010    Key Record Dates
Last Update Posted: August 7, 2015
Last Verified: August 2015
Additional relevant MeSH terms:
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Disease
Depressive Disorder
Depression
Depressive Disorder, Major
Pathologic Processes
Mood Disorders
Mental Disorders
Behavioral Symptoms
Quetiapine Fumarate
Antidepressive Agents
Psychotropic Drugs
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs