Status:
COMPLETED
Effectiveness Study of Mirtazapine Combined With Paroxetine in Major Depressive Patients Without Early Improvement
Lead Sponsor:
Capital Medical University
Conditions:
Major Depression
Eligibility:
All Genders
18-60 years
Phase:
PHASE4
Brief Summary
Although treatment guidelines manifest that antidepressant response usually appear with a delay of several weeks and suggest that treatment should be changed if a partial response has not occurred aft...
Detailed Description
Mirtazapine has significant advantages in response and remission rates compared with various SSRIs in double-blind treatment. Mirtazapine combined with SSRIs or venlafaxine was also found to be one of...
Eligibility Criteria
Inclusion
- Has given written informed consent.
- Male or female outpatients aged at least 18 years and not more than 60 years.
- Has a diagnosis of major depressive disorder by Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) criteria.
- HAMD-17 ≥ 20 and HAMD-17 Item 1(depressed mood) score ≥2 at enrolment in open-label preliminary phase.
Exclusion
- Currently enrolled in, or discontinued within the last 30 days from, a clinical trial involving an off-label use of an investigational drug.
- Current Axis I primary psychiatric diagnosis other than major depressive disorder.
- Organic mental disease, including mental retardation.
- History of clinically significant disease, including any cardiovascular, hepatic, renal, respiratory, hematologic, endocrinologic, or neurologic disease, or clinically significant laboratory abnormality that is not stabilized or is anticipated to require treatment during the study.
- Subjects receiving an investigational agent (including different formulation and generic agents of investigational drug) in the previous 3 months prior to screening.
- Women in pregnancy or lactation, or female of child bearing potential without appropriate birth control measures.
- Use of antipsychotics or mood stabilizers within 5 days prior to screening.
- Has received depot antipsychotic medication within one cycle prior to screening.
- Known allergy or lack of response to mirtazapine.
- Has received ECT or MECT within 3 months prior to screening.
- Significant risk of suicidal and/or self-harm behaviors.
Key Trial Info
Start Date :
November 14 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 24 2016
Estimated Enrollment :
525 Patients enrolled
Trial Details
Trial ID
NCT01458626
Start Date
November 14 2012
End Date
August 24 2016
Last Update
August 31 2017
Active Locations (1)
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1
Beijing Anding Hospital
Beijing, Beijing Municipality, China, 100088