Effectiveness Study of Mirtazapine Combined With Paroxetine in Major Depressive Patients Without Early Improvement

NCT01458626 | Completed Phase 4 DMC

• 1 other identifier: MISP # 39888
• Study Type: interventional
• Target: 525
• Locations: 1 country
• Sites: 1

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 after 4\~6 week, these beliefs are no longer held by experts, and a new concept is raised that the first 2 weeks of treatment may be a useful strategy for improving the management of depression. New evidence indicates that early treatment response can be predicted with high sensitivity after 2 weeks of treatment in patients with major depressive disorder (MDD). Early improvement not only predicted response or remission, but also that lack of improvement was associated with little chance of response if the treatment strategy remained unchanged. The criterion of a 20% score reduction has been chosen as an early indicator of improvement because it can be reliably measured in clinical trials and translates into a clinically relevant change in the severity of depressive symptoms. Antidepressants that enhance both serotonergic and noradrenergic neurotransmission may be more effective than selective serotonin reuptake inhibitors (SSRIs) for acute-phase therapy of major depressive disorder. As a noradrenergic and specific serotonergic antidepressant, the antidepressive mechanism of mirtazapine is quite superior to SSRI and in particular has been suggested to have a faster onset of action than SSRIs in MDD patients. The aim of this study is to provide physicians with further information regarding early improvement and the effectiveness of mirtazapine combined with a SSRI antidepressant therapy in nonresponders.

Conditions

Major Depression

Keywords

mirtazapine; paroxetine; major depression; early improvement

Outcome Measures

Primary Outcomes (1)

• Symptoms Improvement by HAMD-17

  Change of 17-item Hamilton Depression Scale (HAMD-17) total score

  From randomization (Week 2) to endpoint(Week 8)

Secondary Outcomes (10)

• Self-reported improvement by QIDS-SR

  From randomization (Week 2) to endpoint(Week 8)

• Remission rate by HAMD-17

  From randomization (Week 2) to endpoint(Week 8)

• Remission rate by QIDS-SR

  From randomization (Week 2) to endpoint(Week 8)

• Response rate HAMD-17

  From randomization (Week 2) to endpoint(Week 8)

• Response rate by QIDS-SR

  From randomization (Week 2) to endpoint(Week 8)

Study Arms (3)

Add-on therapy

ACTIVE COMPARATOR

mirtazapine 30mg QD and paroxetine 20mg QD

Drug: mirtazapine; Drug: paroxetine 20mg QD

mirtazapine monotherapy

ACTIVE COMPARATOR

mirtazapine 30mg QD

Drug: mirtazapine

paroxetine monotherapy

ACTIVE COMPARATOR

paroxetine 20mg QD

Drug: paroxetine 20mg QD

Interventions

mirtazapine DRUG

mirtazapine 30mg QD

Also known as: Remeron

Add-on therapy; mirtazapine monotherapy

paroxetine 20mg QD DRUG

paroxetine 20mg QD

Also known as: Seroxat

Add-on therapy; paroxetine monotherapy

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Capital Medical University: lead

Study Sites (1)

Beijing Anding Hospital

Beijing, Beijing Municipality, 100088, China

Location

Related Publications (1)

• Zhou J, Liu S, Mayes TL, Feng Y, Fang M, Xiao L, Wang G. The network analysis of depressive symptoms before and after two weeks of antidepressant treatment. J Affect Disord. 2022 Feb 15;299:126-134. doi: 10.1016/j.jad.2021.11.059. Epub 2021 Nov 24.

  PMID: 34838606 DERIVED

MeSH Terms

Conditions

Depressive Disorder, Major

Interventions

Mirtazapine; Paroxetine

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Dibenzazepines; Heterocyclic Compounds, 3-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Piperidines; Heterocyclic Compounds, 1-Ring

Study Officials

• Gang Wang, M.D., Ph.D

  Beijing Anding Hospital, Capital Medical University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Depression Center

Study Record Dates

• First Submitted: August 9, 2011
• First Posted: October 25, 2011
• Study Start: November 14, 2012
• Primary Completion: August 24, 2016
• Study Completion: August 24, 2016
• Last Updated: August 31, 2017

Record last verified: 2017-08

Locations

CN (1)