Effect of Quetiapine XR on Sleep in Patients With Major Depression, as Compared With Mirtazapine

This study has been completed.
Sponsor:
Information provided by:
Technische Universität München
ClinicalTrials.gov Identifier:
NCT00782405
First received: October 24, 2008
Last updated: April 18, 2011
Last verified: April 2011

October 24, 2008
April 18, 2011
October 2008
April 2011   (final data collection date for primary outcome measure)
sleep effiency [ Time Frame: n.a. ] [ Designated as safety issue: No ]
sleep effiency [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00782405 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
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Not Provided
 
Effect of Quetiapine XR on Sleep in Patients With Major Depression, as Compared With Mirtazapine
Effect of Quetiapine XR on Sleep in Patients With Major Depression, as Compared With Mirtazapine

The purpose of this study is to examine the effects of (a) quetiapine XR and (b) mirtazapine on sleep when given as an antidepressant (monotherapy). We hypothesize that (a) quetiapine XR has an immediate and lasting positive effect on sleep in depressed patients which does not differ from the impact of mirtazapine on sleep in this group of patients; (b) in the context of a secondary objective, we expect an antidepressant effect of quetiapine XR which is equivalent to that of mirtazapine.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Sleep
  • Drug: quetiapine
    XR, 150-300mg
  • Drug: mirtazapine
    30-45 mg
  • Experimental: 1
    quetiapine
    Intervention: Drug: quetiapine
  • Active Comparator: 2
    mirtazapine
    Intervention: Drug: mirtazapine
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
40
Not Provided
April 2011   (final data collection date for primary outcome measure)

Inclusion Criteria:

  1. Provision of written informed consent
  2. A diagnosis of Major depressive disorder by Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, revised (DSM-IV-R)
  3. Clinically significant sleep disturbance (PSQI total score > 5)
  4. Females and males aged 18 to 65 years
  5. Female patients of childbearing potential must be using a reliable method of contraception and have a negative urine human chorionic gonadotropin (HCG) test at enrolment
  6. Able to understand and comply with the requirements of the study
  7. Minimum score in the HAMD-21 scale: 18

Exclusion Criteria:

  1. Pregnancy or lactation
  2. Any DSM-IV-R Axis I disorder not defined in the inclusion criteria
  3. Patients who, in the opinion of the investigator, pose an imminent risk of suicide or a danger to self or others
  4. Known intolerance or lack of response to quetiapine fumarate and / or mirtazapine, as judged by the investigator
  5. 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
  6. Use of any of the following cytochrome P450 3A4 inducers in the 14 days preceding enrolment including but not limited to: phenytoin, carbamazepine, barbiturates, rifampicin, St. John's Wort, and glucocorticoids
  7. Administration of a depot antipsychotic injection within one dosing interval (for the depot) before randomisation
  8. Substance or alcohol dependence at enrolment (except dependence in full remission, and except for caffeine or nicotine dependence), as defined by DSM-IV-R criteria
  9. Opiates, amphetamine, barbiturate, cocaine, cannabis, or hallucinogen abuse by DSM-IV-R criteria within 4 weeks prior to enrolment
  10. Medical conditions that would affect absorption, distribution, metabolism, or excretion of study treatment
  11. Unstable or inadequately treated medical illness (e.g. congestive heart failure, angina pectoris, hypertension) as judged by the investigator
  12. Involvement in the planning and conduct of the study
  13. Previous enrolment or randomisation of treatment in the present study.
  14. Participation in another drug trial within 4 weeks prior enrolment into this study or longer in accordance with local requirements
  15. A patient with Diabetes Mellitus (DM) fulfilling one of the following criteria:

    • Unstable DM defined as enrolment glycosylated hemoglobin (HbA1c) >8.5%.
    • Admitted to hospital for treatment of DM or DM related illness in past 12 weeks.
    • Not under physician care for DM
    • Physician responsible for patient's DM care has not indicated that patient's DM is controlled.
    • Physician responsible for patient's DM care has not approved patient's participation in the study
    • Has not been on the same dose of oral hypoglycaemic drug(s) and/or diet for the 4 weeks prior to randomisation. For thiazolidinediones (glitazones) this period should not be less than 8 Weeks.
    • Taking insulin whose daily dose on one occasion in the past 4 weeks has been more than 10% above or below their mean dose in the preceding 4 weeks Note: If a diabetic patient meets one of these criteria, the patient is to be excluded even if the treating physician believes that the patient is stable and can participate in the study.
  16. An absolute neutrophil count (ANC) of ≤ 1.5 x 109 per liter
  17. Respiratory distress index during the 1st polysomnography > 10
  18. Periodic leg movement / arousal index during the 1st polysomnography > 10
Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT00782405
D114432C00027
No
Technical University of Munich, TechnischeUM
Technische Universität München
Not Provided
Principal Investigator: Michael H Wiegand, Prof. Sleep Disorders Center
Technische Universität München
April 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP