The Measurement-based Care in Patients With Depressive Disorder: A Randomized Controlled Trial

NCT02191124 | Completed Phase 4 DMC

• 1 other identifier: 2009-1051
• Study Type: interventional
• Target: 164
• Locations: 1 country
• Sites: 1

Brief Summary

In recent years, measurement-based care (MBC) has been gaining more attention in the treatment of depression because it allows psychiatrists to individualize treatment decisions for each patient based on the change of psychopathology and tolerance toward antidepressants. Several studies, such as the Sequenced Treatment Alternatives to Relieve Depression (STAR\*D) trial using MBC, found that MBC-informed sequential algorithms can be successfully integrated into clinical practice and improve patients' outcomes However, despite a strong theoretical rationale for MBC and data supporting the ability to implement MBC in clinical practice settings, there is currently no randomized controlled trial in MDD patients comparing MBC with usual/standard care. The investigators compare MBC with clinician's treatment decisions, standardizing care to two commonly prescribed antidepressants. Therefore, the aim of this study is to determine the effects of MBC in patients with MDD compared to standard treatment (ST). The research hypothesis is that compared to ST, the estimated time to response and to remission would be significantly shorter in the MBC group without increased dropout rates and side effect burden.

Conditions

Major Depressive Disorder

Keywords

Measurement-based care; Unipolar depression; Outpatients

Outcome Measures

Primary Outcomes (1)

• The estimated time from randomization to response and remission according to Hamilton Rating Scale for Depression (HAMD) total score.

  Response was defined as ≥50% decrease in the baseline HAMD total score; remission was defined as the HAMD total score ≤7

  From randomization to response and remission (24 week))

Secondary Outcomes (6)

• The changes of Hamilton Rating Scale for Depression (HAMD) total score

  From randomization to endpoint (Week 24)

• The incidence and nature of overall adverse events

  From enrollment to endpoint (Week 24)

• The incidence and nature of drug-related adverse events

  From enrollment to endpoint (Week 24)

• The number of subject withdrawal due to adverse events during double-blind phase

  From randomization to endpoint(Week 24)

• The changes of Quick Inventory of Depressive Symptomatology-Self-Report (QIDS-SR) total score

  From randomization to endpoint (Week 24)

Study Arms (2)

measurement-based care

EXPERIMENTAL

MBC allows psychiatrists to individualize treatment decisions for each patient based on the change of psychopathology and tolerance toward antidepressants. Treatment decisions were made by treating psychiatrists according to ratings of self-report scales obtained at each treatment visit. Paroxetine was started at 20mg/day and then raised to 30mg/day by week 4, 40mg/day by week 6, 50mg/day by week 8 and 60mg/day by week 10. Mirtazapine was started at 15mg/day and raised to 30mg/day by week 1 and 45mg/day by week 4. Dose adjustments were dependent on how long a patient had received a particular dose, symptom changes and side effects.

Drug: Paroxetine; Drug: Mirtazapine

Standard treatment

ACTIVE COMPARATOR

Patients in the ST group are treated by their psychiatrists according to their clinical needs as judged at each outpatient visit, receiving either open-label paroxetine (20-60mg/day) or mirtazapine (15-45mg/day) within the therapeutic dose range.

Drug: Paroxetine; Drug: Mirtazapine

Interventions

Paroxetine DRUG

Patients in both groups (MBC or ST) receive open-label paroxetine (20-60mg/day) within the therapeutic dose range recommended by the Guidelines for the Prevention and Treatment of Major Depression in China.

Also known as: Seroxat

Standard treatment; measurement-based care

Mirtazapine DRUG

Patients in both groups (MBC or ST) receive open-label mirtazapine (15-45mg/day) within the therapeutic dose range recommended by the Guidelines for the Prevention and Treatment of Major Depression in China

Also known as: Remeron

Standard treatment; measurement-based care

Eligibility Criteria

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

You may qualify if:

• age 18-65 years;
• outpatients;
• diagnosis of non-psychotic MDD established by treating psychiatrists and confirmed by a checklist based on DSM-IV criteria at study entry ;
• total score of HAMD-17≥17;
• ability to communicate and provide written consent.

You may not qualify if:

• current or past history of drug and alcohol dependence, bipolar, psychotic, obsessive-compulsive, or eating disorders;
• history of lack of response or intolerance to any of the two protocol antidepressants (paroxetine or mirtazapine);
• being pregnant or breast-feeding;
• suicide attempts in the current depressive episode or major medical conditions contraindicating the use of the protocol antidepressants.

Sponsors & Collaborators

• Capital Medical University: lead

Study Sites (1)

Beijing Anding Hospital

Beijing, Beijing Municipality, 100088, China

Location

MeSH Terms

Conditions

Depressive Disorder, Major; Depressive Disorder

Interventions

Paroxetine; Mirtazapine

Condition Hierarchy (Ancestors)

Mood Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

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

Study Officials

• Gang Wang, MD;PhD

  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: vice-director of Affective Disorder Center, Beijing Anding Hospital

Study Record Dates

• First Submitted: July 10, 2014
• First Posted: July 16, 2014
• Study Start: June 1, 2011
• Primary Completion: November 1, 2012
• Study Completion: May 1, 2013
• Last Updated: July 16, 2014

Record last verified: 2014-07

Locations

CN (1)