Lead Investigator: Andrea Cipriani, University of Oxford
Title of Proposal Research: Choosing the Right Antidepressant for Depressive Disorder in Adults: Individual Patient Data Network Meta-Analysis
Vivli Data Request: 4917
Funding Source: National Institute of Health Research
Potential Conflicts of Interest: Andrea Cipriani has received research and consultancy fees from INCiPiT (Italian Network for Paediatric Trials), CARIPLO Foundation and Angelini Pharma.
Anneka Tomlinson has received research and consultancy fees from INCiPiT (Italian Network for Paediatric Trials), and Angelini Pharma.
Summary of the Proposed Research:
Mental illness is a major cause of global health burden, accounting for 23% of years lived with disability. With 350 million people affected in the world, depressive disorder is the second leading cause of global burden and poses a significant challenge for health systems worldwide. The high direct and indirect costs for major depression are substantially due to significant deficits in treatment provision. There are a number of efficacious interventions for depressive disorder and the key challenge is how best to implement currently available effective treatments.3 International guidelines recommend antidepressant drugs as first line treatment for adults with moderate to severe depression. About 80% of people in primary care in the UK receive an antidepressant prescription in the first year of diagnosis.6 However, the majority of prescriptions are for less than 30 days, while an adequate trial of antidepressants is generally recommended to be 6-8 weeks before changing or stopping the medication. A too short duration of treatment both limits the therapeutic effect6 and increases the risk of withdrawal symptoms because antidepressants should be tapered off over a period of 4 weeks. While a number of factors contribute to sub-optimal treatment durations, two of the most prominent are the initial side effects of the medication and their perceived marginal efficacy. These factors are exacerbated by our current inability to predict which drug will causes the fewest adverse effects for a specific patient, and which will work most effectively. Better methods of tailoring treatment to individuals are urgently needed, despite being recognised by international guidelines, to date there are currently no reliable ways of achieving this. In fact, however, major opportunities are available to improve patients’ outcomes with existing therapies by the efficient use of available clinical trial data combined with technical advance in data synthesis and longterm outcomes from real-world datasets. Such analyses can now predict the probability of response for a specific subgroup of patients or estimate the chances that a person will have a particular side effect. By matching patients to individual antidepressants, clinicians can more precisely customise treatment to patients’ needs and thus improve their outcome. Precision medicine is now a leading aim of healthcare internationally. Currently, the process of matching patients with treatments is too often by trial and error, delaying clinical improvement and increasing the risks and costs associated with treatment. Pooling an analysis of clinical trial data may provide “personalised” estimates of comparative effectiveness, stratified for specific subgroups of patients to predict “individualised” response to treatment. Despite the recent progress in this field, psychiatry continues to lag behind other areas of medicine including cardiology, oncology, immunology and neurology.
Aim
This project specially aims to develop and test a novel precision medicine approach to the optimise the medical (drug) treatment of depressive disorder, which can be used in everyday clinical settings. We aim to develop a web-based platform using large and diverse datasets combining data from hundreds of thousands of patients, to inform shared decision-making at the individual patient level during the routine consultation between doctors and patients. The first phase of this project is obtaining individual patient data which will form a vital part of the dataset.
Requested Studies:
A Phase 3, Open-label, Long-Term Study to Evaluate the Safety of LY110140 Once Daily Dosing for 52-week in Japanese Patients With Major Depressive Disorder
Data Contributor: Lilly
Study ID: NCT01808651
Sponsor ID: 14596
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
Duloxetine Versus Placebo in the Acute Treatment of Patients With Major Depressive Disorder and Associated Painful Physical Symptoms
Data Contributor: Lilly
Study ID: NCT01070329
Sponsor ID: 13630
A Phase 4, 8-Week, Double-Blind, Randomized, Placebo-Controlled Study Evaluating the Efficacy of Duloxetine 60 mg Once Daily in Outpatients With Major Depressive Disorder and Associated Painful Physical Symptoms
Data Contributor: Lilly
Study ID: NCT01000805
Sponsor ID: 13399
A Phase 4 Comparison of Duloxetine Dosing Strategies in the Treatment of Korean Patients With Major Depressive Disorder
Data Contributor: Lilly
Study ID: NCT00960986
Sponsor ID: 9884
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 Randomised, Double-blind, Parallel-group, Placebo-controlled, Duloxetine-referenced, Fixed-dose Study Evaluating the Efficacy and Safety of Three Dosages of [Vortioxetine] Lu AA21004, in Acute Treatment of Major Depressive Disorder
Data Contributor: Lundbeck
Study ID: NCT00635219
Sponsor ID: 11984A
Randomised, Double-blind, Parallel-group, Placebo-controlled, Duloxetine-referenced, Fixed Dose Study Comparing the Efficacy and Safety of [Vortioxetine] Lu AA21004 in Acute Treatment of Major Depressive Disorder in Elderly Patients
Data Contributor: Lundbeck
Study ID: NCT00811252
Sponsor ID: 12541A
A Randomised, Double-blind, Parallel-group, Placebo-controlled, Duloxetine-referenced, Fixed-dose Study Evaluating the Efficacy and Safety of Lu AA21004 (15 and 20 mg/Day) in the Acute Treatment of Adult Patients With Major Depressive Disorder
Data Contributor: Lundbeck
Study ID: NCT01140906
Sponsor ID: 13267A
Randomised, Double-blind, Parallel-group, Active-comparator (Venlafaxine Extended Release), Fixed-dose Study of [Vortioxetine] Lu AA21004 in Major Depressive Disorder in Asian Countries
Data Contributor: Lundbeck
Study ID: NCT01571453
Sponsor ID: 13926A
Randomised, Double-blind, Parallel-group, Placebo-controlled, Fixed Dose Study on the Efficacy of [Vortioxetine] Lu AA21004 on Cognitive Dysfunction in Adult Patients With Major Depressive Disorder (MDD)
Data Contributor: Lundbeck
Study ID: NCT01422213
Sponsor ID: 14122A
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
An eight-week double-blind study comparing the effects of 20 mg of paroxetine to 150 mg of Wellbutrin SR in patients with Major Depressive Disorder
Data Contributor: GlaxoSmithKline
Study ID: WELL AK140016
Sponsor ID: WELL AK140016
Lilly Study 1
Data Contributor: Lilly
Study ID: B1Y-MC-HCAF
Sponsor ID: B1Y-MC-HCAF
Lilly Study 2
Data Contributor: Lilly
Study ID: B1Y-MC-HCFF
Sponsor ID: B1Y-MC-HCFF
Lilly Study 3
Data Contributor: Lilly
Study ID: B1Y-MC-HCCP
Sponsor ID: B1Y-MC-HCCP
Lilly Study 4
Data Contributor: Lilly
Study ID: B1Y-MC-HCDB
Sponsor ID: B1Y-MC-HCDB
Lilly Study 5
Data Contributor: Lilly
Study ID: B1Y-MC-HCEX
Sponsor ID: B1Y-MC-HCEX
Lilly Study 6
Data Contributor: Lilly
Study ID: B1Y-MC-HCFP
Sponsor ID: B1Y-MC-HCFP
Lilly Study 7
Data Contributor: Lilly
Study ID: B1Y-MC-HCIB
Sponsor ID: B1Y-MC-HCIB
Lilly Study 8
Data Contributor: Lilly
Study ID: F1J-AA-HMCV
Sponsor ID: F1J-AA-HMCV
Lilly Study 9
Data Contributor: Lilly
Study ID: F1J-US-HMCR
Sponsor ID: F1J-US-HMCR
Lilly Study 10
Data Contributor: Lilly
Study ID: F1J-US-HMFS
Sponsor ID: F1J-US-HMFS
Lilly Study 11
Data Contributor: Lilly
Study ID: F1J-MC-HMBU
Sponsor ID: F1J-MC-HMBU
Lilly Study 12
Data Contributor: Lilly
Study ID: F1J-MC-HMCQ
Sponsor ID: F1J-MC-HMCQ
Lilly Study 13
Data Contributor: Lilly
Study ID: F1J-MC-HMBV
Sponsor ID: F1J-MC-HMBV
Lilly Study 14
Data Contributor: Lilly
Study ID: F1J-US-HMFA
Sponsor ID: F1J-US-HMFA
Duloxetine Once-Daily Dosing Versus Placebo in the Acute Treatment of Major Depression
Data Contributor: Lilly
Study ID: F1J-MC-HMBH(A)
Sponsor ID: F1J-MC-HMBH(A)
Duloxetine Once-Daily Dosing Versus Placebo in the Acute Treatment of Major Depression
Data Contributor: Lilly
Study ID: F1J-MC-HMBH(B)
Sponsor ID: F1J-MC-HMBH(B)
Duloxetine Versus Placebo and Paroxetine in the Treatment of Major Depression
Data Contributor: Lilly
Study ID: F1J-MC-HMAY(A)
Sponsor ID: F1J-MC-HMAY(A)
Duloxetine Versus Placebo in the Treatment of Major Depression
Data Contributor: Lilly
Study ID: F1J-MC-HMAQ(A)
Sponsor ID: F1J-MC-HMAQ(A)
Duloxetine Versus Placebo and Paroxetine in the Acute Treatment of Major Depression
Data Contributor: Lilly
Study ID: F1J-MC-HMAT(A)
Sponsor ID: F1J-MC-HMAT(A)
Duloxetine Versus Placebo and Paroxetine in the Acute Treatment of Major Depression
Data Contributor: Lilly
Study ID: F1J-MC-HMAT(B)
Sponsor ID: F1J-MC-HMAT(B)
Duloxetine Versus Placebo and Paroxetine in the Treatment of Major Depression
Data Contributor: Lilly
Study ID: F1J-MC-HMAY(B)
Sponsor ID: F1J-MC-HMAY(B)
Duloxetine Versus Placebo in the Treatment of Major Depression
Data Contributor: Lilly
Study ID: F1J-MC-HMAQ(B)
Sponsor ID: F1J-MC-HMAQ(B)
Lundbeck study 1
Data Contributor: Lundbeck
Study ID: LB/85A
Sponsor ID: LB/85A
Lundbeck study 2
Data Contributor: Lundbeck
Study ID: LB/86141
Sponsor ID: LB/86141
Lundbeck study 3
Data Contributor: Lundbeck
Study ID: LB/89303
Sponsor ID: LB/89303
Lundbeck study 4
Data Contributor: Lundbeck
Study ID: LB/89306
Sponsor ID: LB/89306
Lundbeck study 5
Data Contributor: Lundbeck
Study ID: LB/91206
Sponsor ID: LB/91206
Lundbeck study 6
Data Contributor: Lundbeck
Study ID: LB/10351
Sponsor ID: LB/10351
Lundbeck study 7
Data Contributor: Lundbeck
Study ID: LB/99001
Sponsor ID: LB/99001
Lundbeck study 8
Data Contributor: Lundbeck
Study ID: LB/99003
Sponsor ID: LB/99003
Lundbeck study 9
Data Contributor: Lundbeck
Study ID: LB/99022
Sponsor ID: LB/99022