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Early Improvement in Individual Symptoms and Response to Antidepressants in Patients With Major Depressive Disorder

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02934035
Recruitment Status : Unknown
Verified October 2016 by prof. Peter de Jonge, University Medical Center Groningen.
Recruitment status was:  Active, not recruiting
First Posted : October 14, 2016
Last Update Posted : October 17, 2016
Information provided by (Responsible Party):
prof. Peter de Jonge, University Medical Center Groningen

Brief Summary:

Major depressive disorder (MDD) affects around 7% of the population yearly. Although effective treatments are available, only around half of all patients participating in clinical trials respond to 6 to 12 weeks of antidepressant treatment. Given these high failure rates, the ability to predict as early as possible whether a patient is (un)likely to respond would be of great value, as it would enable physicians to change treatment strategies faster.

Early improvement has consistently been found to be a strong predictor of later response. However, misclassification is still quite common, with perhaps a third of those who do not show early improvement going on to respond. Conversely, a substantial proportion of those who do show early improvement do not go on to respond. One possibility for improving the predictive power of early improvement is to examine individual symptoms, rather than the total score on a depression rating scale. Some items, for example, could reflect antidepressant side effects (e.g. gastrointestinal symptoms) and may not be very predictive.

The proposed project aims to examine the relationship between early improvement in individual symptoms and response to antidepressants in a very large patient sample. This large sample size makes it possible to use more rigorous methods than previous studies, such as the use of cross-validation to confirm the findings. It also makes it possible to examine a large set of predictors, including possible interactions among early-improving symptoms and between symptoms and demographic factors like age and gender. The added value of individual symptoms over and above using the total symptom score alone will also be examined, as well as possible differences between different antidepressant classes.

The project will use penalized (lasso) regression, which is well-suited to analyzing data with a large number of (potentially highly correlated) predictors. In the primary analysis, response after 6 weeks of treatment will be predicted. In secondary analyses, remission at week 6 and response and remission at week 12 will also be predicted.

Condition or disease Intervention/treatment
Major Depressive Disorder Drug: Antidepressant

  Show Detailed Description

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Study Type : Observational
Estimated Enrollment : 10000 participants
Time Perspective: Prospective
Study Start Date : September 2016
Estimated Primary Completion Date : September 2017
Estimated Study Completion Date : September 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Antidepressants

Group/Cohort Intervention/treatment
The placebo group includes participants in eligible clinical trials who have been assigned to placebo medication.
The antidepressant group includes participants in eligible clinical trials who have been assigned to antidepressant medication.
Drug: Antidepressant
Other Names:
  • Duloxetine
  • Paroxetine
  • Escitalopram
  • Fluoxetine
  • Venlafaxine

Primary Outcome Measures :
  1. Response [ Time Frame: Week 6 ]
    Response is defined as a change of >=50% on the Hamilton Depression Rating Scale (HDRS, 17-item version) from baseline to week 6 (±1) of the trial.

Secondary Outcome Measures :
  1. Remission [ Time Frame: Week 6 ]
    Remission is defined as attaining a score of <=7 on the Hamilton Depression Rating Scale (HDRS-17) at week 6 (±1).

  2. Response [ Time Frame: Week 12 ]
    Response is defined as a change of >=50% on the Hamilton Depression Rating Scale (HDRS, 17-item version) from baseline to week 12 (±1) of the trial.

  3. Remission [ Time Frame: Week 12 ]
    Remission is defined as attaining a score of <=7 on the Hamilton Depression Rating Scale (HDRS-17) at week 12 (±1).

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
The study population consists of participants in randomized controlled trials of FDA-approved antidepressants and of non-approved new chemical entities (if an FDA-approved antidepressant was used as an active comparator) for the treatment of major depressive disorder.

Inclusion Criteria:

  • Minimum duration of double-blind treatment of 6 weeks
  • Participants must have a valid baseline, 2-week and 6 (±1)- or 12 (±1)-week Hamilton Depression Rating Scale score
  • Aged 18 years or older
  • Participants must have been assigned to either placebo or to an FDA-approved antidepressant

Exclusion Criteria:

  • Inclusion criteria of the trial specify a specific subtype of MDD (e.g. MDD and anxiety; MDD and pain)

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Responsible Party: prof. Peter de Jonge, Professor of Psychiatric Epidemiology, University Medical Center Groningen Identifier: NCT02934035     History of Changes
Other Study ID Numbers: 1575
First Posted: October 14, 2016    Key Record Dates
Last Update Posted: October 17, 2016
Last Verified: October 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Depressive Disorder
Depressive Disorder, Major
Mood Disorders
Mental Disorders
Behavioral Symptoms
Antidepressive Agents
Psychotropic Drugs