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

NCT00782405 | Completed Phase 3

• 1 other identifier: D114432C00027
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Sleep

Keywords

antidepressant action; clinical psychopharmacology

Outcome Measures

Primary Outcomes (1)

• sleep effiency

Study Arms (2)

1

EXPERIMENTAL

quetiapine

Drug: quetiapine

2

ACTIVE COMPARATOR

mirtazapine

Drug: mirtazapine

Interventions

quetiapine DRUG

XR, 150-300mg

1

mirtazapine DRUG

30-45 mg

2

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Provision of written informed consent
• A diagnosis of Major depressive disorder by Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, revised (DSM-IV-R)
• Clinically significant sleep disturbance (PSQI total score \> 5)
• Females and males aged 18 to 65 years
• 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
• Able to understand and comply with the requirements of the study
• Minimum score in the HAMD-21 scale: 18

You may not qualify if:

• Pregnancy or lactation
• Patients who, in the opinion of the investigator, pose an imminent risk of suicide or a danger to self or others
• Known intolerance or lack of response to quetiapine fumarate and / or mirtazapine, as judged by the investigator
• 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, rifampicin, 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-R criteria
• Opiates, amphetamine, barbiturate, cocaine, cannabis, or hallucinogen abuse by DSM-IV-R criteria within 4 weeks prior to enrolment
• Medical conditions that would affect absorption, distribution, metabolism, or excretion of study treatment
• Unstable or inadequately treated medical illness (e.g. congestive heart failure, angina pectoris, hypertension) as judged by the investigator
• Involvement in the planning and conduct of the study
• 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
• A patient with Diabetes Mellitus (DM) fulfilling one of the following criteria:
• Unstable DM defined as enrolment glycosylated hemoglobin (HbA1c) \>8.5%.

Sponsors & Collaborators

• Technical University of Munich: lead

Study Sites (1)

Sleep Disorders Center

Munich, Bavaria, 81675, Germany

Location

MeSH Terms

Interventions

Quetiapine Fumarate; Mirtazapine

Intervention Hierarchy (Ancestors)

Dibenzothiazepines; Thiazepines; Thiepins; Sulfur Compounds; Organic Chemicals; Heterocyclic Compounds, 3-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Dibenzazepines

Study Officials

• Michael H Wiegand, Prof.

  Sleep Disorders Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: October 24, 2008
• First Posted: October 31, 2008
• Study Start: October 1, 2008
• Primary Completion: April 1, 2011
• Last Updated: April 19, 2011

Record last verified: 2011-04

Locations

DE (1)