This study investigates two different approaches to the change in antidepressant treatment when an initial treatment is not effective: early intervention or delayed intervention. Two hypothesis will be tested: 1. that time to confirmed response is shorter in the early intervention strategy vs. delayed intervention strategy 2. that the time to confirmed remission is shorter in the early intervention strategy compared to delayed intervention strategy.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
840
Flexible dose of 60 or 120 mg daily
10 mg in both Early and Delayed Intervention. Flexible dose of 10 to 20 mg daily in Delayed Intervention.
Time to Confirmed Response by ≥ 50% Change From Baseline Reduction in the Hamilton Depression Rating Scale-17 Items (HAMD-17)
Time to confirmed response is defined as the time from the day of study randomization (Visit 2) to the date of first observation of confirmed response defined as ≥ 50% baseline score reduction on the HAMD-17 for 2 consecutive visits. The 17-item HAMD measures depression severity. Each item was evaluated and scored using either a 5-point scale, e.g. absent, mild, moderate, severe, very severe) or a 3-point scale (e.g. absent, mild, marked). The total score of HAMD-17 may range from 0 (normal) to 52 (severe).
Time frame: Week 4 through Week 16
Estimated Probability of Not Reaching Confirmed Response at 12 Weeks Based on the Survival Function for the Time to Confirmed Response
Survival function is estimating the probability of participants not achieving confirmed response after 12 weeks. Confirmed response is defined as \>=50% change from baseline reduction in the Hamilton Depression Rating Scale-17 Items (HAMD-17). The 17-item HAMD measures depression severity. Each item was evaluated and scored using either a 5-point scale (e.g. absent, mild, moderate, severe, very severe) or a 3-point scale (e.g. absent, mild, marked). The total score of HAMD-17 may range from 0 (normal) to 52 (severe).
Time frame: Week 4 through Week 16
Time to Confirmed Remission by a Hamilton Depression Rating Scale-17 Items (HAMD-17) Score of ≤ 7 That is Maintained for Two Consecutive Visits
Time to confirmed remission is defined as the time from the day of study randomization (Visit 2) to the date of first observation of confirmed remission defined as a score on the HAMD-17 of ≤ 7 for 2 consecutive visits. The 17-item HAMD measures depression severity. Each item was evaluated and scored using either a 5-point scale (e.g. absent, mild, moderate, severe, very severe) or a 3-point scale (e.g. absent, mild, marked). The total score of HAMD-17 may range from 0 (normal) to 52 (severe).
Time frame: Week 4 through Week 16
Estimated Probability of Not Reaching Confirmed Remission at 12 Weeks Based on the Survival Function for the Time to Confirmed Remission
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Copenhagen, Denmark
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Angoulême, France
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Arcachon, France
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Dole, France
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Gujan-Mestras, France
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Marseille, France
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Montpellier, France
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Nîmes, France
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Orvault, France
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Rennes, France
...and 50 more locations
Survival function is estimating the probability of participants not achieving confirmed remission. Confirmed remission is defined as a Hamilton Depression Rating Scale-17 Items (HAMD-17) Score of ≤ 7 that is maintained for two consecutive visits. The 17-item HAMD measures depression severity. Each item was evaluated and scored using either a 5-point scale (e.g. absent, mild, moderate, severe, very severe) or a 3-point scale (e.g. absent, mild, marked). The total score of HAMD-17 may range from 0 (normal) to 52 (severe).
Time frame: Week 4 through Week 16
Time to Confirmed Response as Defined by ≥ 50% Reduction From Baseline Reduction in the 16-Item Quick Inventory of Depressive Symptomatology Self Report (QIDS16SR) That is Reported for Two Consecutive Visits
Time to confirmed response is defined as the time from the day of study randomization (Visit 2) to the date of first observation of confirmed response. QIDS16SR is a 16-item participant-rated measure of depressive symptomatology. The total score ranges from 0 to 27 with higher scores indicative of greater severity.
Time frame: Week 4 through Week 16
Time to Confirmed Remission as Defined by a 16-Item Quick Inventory of Depressive Symptomatology Self Report (QIDS16SR) Score of ≤ 5 That is Maintained for Two Consecutive Visits.
Time to confirmed remission is defined as the time from the day of study randomization (Visit 2) to the date of first observation of confirmed remission. A 16-item participant-rated measure of depressive symptomatology. The total score ranges from 0 to 27 with higher scores indicative of greater severity.
Time frame: Week 4 through Week 16
Clinical Global Impressions of Severity (CGI-S) Scale
Measures severity of illness at the time of assessment compared with start of treatment. Scores range from 1 (normal, not at all ill) to 7 (among the most extremely ill participants).
Time frame: Baseline, Week 4, Week 6, Week 8, Week 10, Week 12, Week 14, Week 16
Visual Analog Scale (VAS) - Overall Pain Severity
VAS for pain consists of 6 questions that assess overall pain, headache, back pain, shoulder pain, pain interference with daily activities, and pain while awake. Participant rates pain on a 10 centimeter (cm) line between two anchors (0= no pain and 10=very severe pain).
Time frame: Baseline, Week 4, Week 6, Week 8, Week 10, Week 12, Week 14, Week 16
Euro Quality of Life Questionnaire-5 Dimensions (EQ-5D) Scale - Health State Score
The EQ-5D Health State Score is self-rated health on a vertical, visual analogue scale measured in centimeters (cm) and reported as units on a scale. Best imaginable health state = 10 cm and worst imaginable health state = 0 cm.
Time frame: Baseline, Week 4, Week 8, Week 12, Week 16
Euro Quality of Life Questionnaire-5 Dimensions (EQ-5D) Scale - United Kingdom (UK) Population Based Index Score
The EQ-5D is a generic, multidimensional, health-related, quality of life instrument. The profile allows participants to rate their health state in 5 health domains: mobility, self-care, usual activities, pain/discomfort, and mood. A single score between 1 and 3 is generated for each domain. For each participant, the outcome rating on the 5 domains will be mapped to a single index through an algorithm. The index ranges between 0 and 1, with the higher score indicating a better health state perceived by the participant.
Time frame: Baseline, Week 4, Week 8, Week 12, Week 16
Sheehan Disability Scale (SDS) Normal Functioning Total Score
The SDS is completed by the participant and is used to assess the effect of the participant's symptoms on their work/social/family life. Total scores range from 0 to 30 with higher values indicating greater disruption in the participant's work/social/family life.
Time frame: Baseline, Week 4, Week 8, Week 12, Week 16
Resource Utilisation - Number of Hours Worked Per Week
Time frame: Baseline, Week 4, Week 8, Week 12, Week 16
Resource Utilisation - Number of Work Hours Missed in the Last 4 Weeks
Only those participants who missed at least 1 hour of work were included.
Time frame: Week 4, Week 8, Week 12, Week 16
Resource Utilisation - Number of Work Hours Missed Due to Depression in the Last 4 Weeks
Only those participants who missed at least 1 hour of work due to depression were included.
Time frame: Week 4, Week 8, Week 12, Week 16
Resource Utilisation - Number of Visits to Primary Healthcare Provider Due to Depression in the Last 4 Weeks
Time frame: Week 4, Week 8, Week 12, Week 16
Resource Utilisation - Number of Visits to Other Specialists Due to Depression in the Last 4 Weeks
Time frame: Week 4, Week 8, Week 12, Week 16
Resource Utilisation - Has the Participant Been Hospitalized Due to Depression in the Last 4 Weeks - Number of Participants With a Yes Response
Time frame: Week 4, Week 8, Week 12, Week 16
Number of Participants With Adverse Events (AEs)
The list of AEs is located in the Reported Adverse Event module.
Time frame: Baseline through Week 16