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

NCT02934035 | Unknown

• 1 other identifier: 1575
• Study Type: observational
• Target: 10,000
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Major Depressive Disorder

Outcome Measures

Primary Outcomes (1)

• Response

  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.

  Week 6

Secondary Outcomes (3)

• Remission

  Week 6

• Response

  Week 12

• Remission

  Week 12

Study Arms (2)

Placebo

The placebo group includes participants in eligible clinical trials who have been assigned to placebo medication.

Antidepressant

The antidepressant group includes participants in eligible clinical trials who have been assigned to antidepressant medication.

Drug: Antidepressant

Interventions

Antidepressant DRUG

Also known as: Duloxetine, Paroxetine, Escitalopram, Fluoxetine, Venlafaxine

Antidepressant

Eligibility Criteria

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

You may qualify if:

• 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

Sponsors & Collaborators

• University Medical Center Groningen: lead

MeSH Terms

Conditions

Depressive Disorder, Major

Interventions

Antidepressive Agents; Duloxetine Hydrochloride; Paroxetine; Escitalopram; Fluoxetine; Venlafaxine Hydrochloride

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Psychotropic Drugs; Central Nervous System Agents; Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses; Thiophenes; Sulfur Compounds; Organic Chemicals; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Piperidines; Propylamines; Amines; Nitriles; Benzofurans; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Cyclohexanols; Hexanols; Fatty Alcohols; Alcohols; Phenethylamines; Ethylamines; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Lipids

Study Design

• Study Type: observational
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Psychiatric Epidemiology

Study Record Dates

• First Submitted: October 13, 2016
• First Posted: October 14, 2016
• Study Start: September 1, 2016
• Primary Completion: September 1, 2017
• Study Completion: September 1, 2017
• Last Updated: October 17, 2016

Record last verified: 2016-10

Data Sharing

• IPD Sharing: Will not share