Do psychometrics matter? The effects of advanced psychometric analyses on depression randomised trial outcomes

Lead Investigator: Frank Doyle, Royal College of Surgeons Ireland
Title of Proposal Research: Do psychometrics matter? The effects of advanced psychometric analyses on depression randomised trial outcomes
Vivli Data Request: 8244
Funding Source: None
Potential Conflicts of Interest: None

Summary of the Proposed Research:
Depression is currently the most common mental health disorder worldwide, with an estimated 5% of the population – or 280 million people – suffering this disorder. Depression can affect how you feel, think and behave and can lead to a range of emotional and physical problems. Depression can be a significant health condition, which can inform poor interpersonal relationships, poor work functionality and, at its worst, can inform suicide ideation.

Symptoms caused by depression can vary from person to person and there are a number of effective treatments to help combat depression. These treatments can be broadly categorised as psychotherapies (talking therapy) that can help a person manage their problems by changing the way they think and behave, and pharmacotherapies, such as taking antidepressant medication. The effectiveness of these treatments is typically examined using psychometric assessment, essentially questionnaires which evaluate patients’ experiences of a range of depressive symptoms. However, despite several advanced and very complex statistical methods being developed to evaluate these questionnaires, it is unclear if using these complex techniques are important for finding changes that matter to patients and clinicians.

A recent analysis of 101 studies of 11,910 people with mostly moderate-severe depression, had some very important findings. Firstly, combination psychotherapy (talking therapy) and antidepressants were more effective than either alone. Secondly, antidepressants and psychotherapies did not differ in effects from each other. These types of multi-study analyses allow for estimation of treatment effects that cannot be achieved by single studies alone. In essence, they show that something really ‘matters’ at a population level in terms of treatment effects.

In this current study we propose to obtain already-collected data from thousands of patients who have already participated in depression treatment studies and combine into a large database. This database will be analysed using advanced psychometric techniques, and the results of these complex techniques compared. Using this large database we aim to determining whether psychometric analysis informs any differences in the original results of these depression treatment studies.

This study could make an important contribution to medical science and patient care by highlighting important differences (including gender differences) in depression symptoms and treatments, and potentially improving the accuracy with which depression is psychometrically assessed.

Requested Studies:
A Multi-centre, Randomised, Double-blind, Parallel Active-controlled Study Evaluating the Efficacy, Safety and Tolerability of Bupropion Hydrochloride Extended-release (Bupropion XL 300mg Once Daily), Escitalopram Oxalate (Escitalopram, 10mg-20mg Once Daily) in Subjects With Major Depressive Disorder
Data Contributor: GlaxoSmithKline
Study ID: NCT02191397
Sponsor ID: 114589

A Phase 3, Randomized, Placebo-Controlled, Double-Blind, Parallel-Design Study to Evaluate the Short-Term, Fixed Dose Efficacy and Safety of LY110140 Once Daily Dosing in Japanese Patients With Major Depressive Disorder
Data Contributor: Lilly
Study ID: NCT01808612
Sponsor ID: 14595

A Phase IV, Multicenter, Randomized, 8-Week, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy of 2 Fixed Doses (50 and 100 mg/Day) of Desvenlafaxine Succinate Sustained-Release (DVS SR) in Adult Outpatients With Major Depressive Disorder
Data Contributor: Pfizer
Study ID: NCT01432457
Sponsor ID: B2061028

A Six Week Randomized, Double-blind, Multi-center, Placebo-controlled, Exploratory, Adaptive Design Study to Explore the Antidepressant Properties of the p38 MAP Kinase Inhibitor GW856553 Compared to Placebo in Adult Subjects With Major Depressive Disorder
Data Contributor: GlaxoSmithKline
Study ID: NCT00976560
Sponsor ID: PKI113009

A Randomised, Double-Blind, Parallel-Group, Placebo-Controlled Study Evaluating the Efficacy and Safety of GSK163090 in Subjects With Major Depressive Disorder
Data Contributor: GlaxoSmithKline
Study ID: NCT00896363
Sponsor ID: 109035

A Multicenter, Double-Blind, Placebo-Controlled, Randomized Withdrawal, Parallel Group Study To Evaluate The Efficacy And Safety Of 50 mg/Day Of DVS SR In Adult Outpatients With Major Depressive Disorder
Data Contributor: Pfizer
Study ID: NCT00887224
Sponsor ID: 3151A1-3360

A Randomized, Double-blind, Placebo Controlled Trial to Evaluate the Clinical Effects of Controlled Release Paroxetine in the Treatment of Major Depressive Disorder
Data Contributor: GlaxoSmithKline
Study ID: NCT00866294
Sponsor ID: 112810

A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study To Evaluate The Efficacy And Safety Of 2 Fixed Doses (10 And 50 mg/Day) Of DVS SR Tablets In Adult Outpatients With Major Depressive Disorder
Data Contributor: Pfizer
Study ID: NCT00863798
Sponsor ID: 3151A1-3362

A Multicenter, Double-Blind, Randomized, Placebo-Controlled Study To Evaluate Functional Outcome In Outpatients With Major Depressive Disorder Treated With Desvenlafaxine Succinare Sustained Release
Data Contributor: Pfizer
Study ID: NCT00824291
Sponsor ID: 3151A1-4415

Comparison of Two Different Treatment Strategies in Patients With Major Depressive Disorder Not Exhibiting Improvement on Escitalopram Treatment: Early vs. Delayed Intervention Strategy
Data Contributor: Lilly
Study ID: NCT00810069
Sponsor ID: 12329

A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of 2 Fixed Doses (25 and 50 mg/Day) of DVS SR Tablets in Adult Outpatients With Major Depressive Disorder
Data Contributor: Pfizer
Study ID: NCT00798707
Sponsor ID: 3151A1-3359

A Randomized, Double-blind, Parallel-Group, Placebo-Controlled, Fixed-Dose Study Comparing the Efficacy and Safety of 3 Doses of Lu AA21004 in Acute Treatment of Adults With Major Depressive Disorder
Data Contributor: Takeda
Study ID: NCT00735709
Sponsor ID: LuAA21004_305