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

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

Psychometric assessment, for example using questionnaires to assess depression, preferences or attitudes, is an integral part of social and clinical sciences, and is included in multiple degree programmes internationally. 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. This project therefore aims to establish whether these psychometric techniques truly matter, either quantitatively or qualitatively, by conducting secondary analyses of individual patient data from depression treatment randomised trials. We will do this by following these steps:-   Obtaining already-collected data from thousands of patients who have already participated in depression treatment studies, including antidepressant trials. We will do this by linking with the investigator's contacts, writing to other investigators and companies and obtaining freely-available data. We will then combine all these studies into a large database.-   Analysing this database using advanced psychometric techniques, including confirmatory factor analysis, item response theory and network analysis, to compare results of various approaches.-  Determining whether there are any quantitative differences in the original effectiveness results of these depression treatment studies once we account for the findings based on the psychometric analyses.- Determining whether there are any qualitative differences in results (e.g. any gender differences in symptom changes, or whether psychotherapy changes different symptoms to antidepressants, even if the total number of symptom changes are similar).

[{ "PostingID": 1617, "Title": "GSK-29060/785", "Description": "A double-blind, placebo-controlled, fixed-dosage study comparing the efficacy and tolerability of paroxetine CR and citalopram to placebo in the treatment of Major Depressive Disorder with anxiety" },{ "PostingID": 1623, "Title": "GSK-MY-1043/BRL-029060/115", "Description": "A multicenter, randomized, double-blind, placebo-controlled comparison of paroxetine and fluoxetine in the treatment of major depressive disorder." },{ "PostingID": 1633, "Title": "GSK-29060/448", "Description": "A Double-Blind, Placebo Controlled Trial to Evaluate the Clinical Effects of Immediate Release Paroxetine and Modified Release Paroxetine in the Treatment of Major Depression" },{ "PostingID": 1634, "Title": "GSK-29060/449", "Description": "A Double-Blind, Placebo Controlled Trial to Evaluate the Clinical Effects of Immediate Release Paroxetine and Modified Release Paroxetine in the Treatment of Major Depression" },{ "PostingID": 1638, "Title": "GSK-29060/810", "Description": "A double-blind, placebo-controlled, 3-arm, fixed-dose study of 12.5 mg/day and 25mg/day Paroxetine CR in the treatment of Major Depression." },{ "PostingID": 1639, "Title": "GSK-29060/874", "Description": "Assessment of Paxil CR, 12.5 and 25 mg/day in treating elderly patients with major depression" },{ "PostingID": 1982, "Title": "GSK-NKF100096", "Description": "A Randomised, Double-Blind, Double-Dummy, Parallel-Group, Placebo-Controlled, Forced Dose Titration Study Evaluating the Efficacy and Safety of GW679769 and Paroxetine in Subjects with Major depressive Disorder (MDD)" },{ "PostingID": 2063, "Title": "GSK-AK130939", "Description": "A Multi-Centre, Randomised, Double-Blind, Parallel-Group, Placebo- and Active-Controlled, Flexible Dose Study Evaluating the Efficacy, Safety and Tolerability of Extended-Release Bupropion Hydrochloride (150mg - 300mg once daily), Extended-Release Venlafaxine Hydrochloride (75mg - 150mg once daily) and Placebo in Subjects with Major Depressive Disorder." },{ "PostingID": 2064, "Title": "GSK-WXL101497", "Description": "A Multi-Centre, Randomised, Double-Blind, Parallel-Group, Placebo- and Active-Controlled, Flexible Dose Study Evaluating the Efficacy, Safety and Tolerability of Extended-Release Bupropion Hydrochloride (150mg - 300mg once daily), Extended-Release Venlafaxine Hydrochloride (75mg - 150mg once daily) and Placebo in Subjects with Major Depressive Disorder." },{ "PostingID": 2067, "Title": "GSK-WELL ZYB40021", "Description": "A 6 Month Multicenter, Randomized, Double-Blind, Pilot Study to Investigate the Tolerability and Efficacy of Bupropion SR Compared to Placebo for the Treatment of Mild Depressive Symptoms and Obesity, Followed by a 24-week Open-Label Extension" },{ "PostingID": 2122, "Title": "GSK-29060/01/001", "Description": "A Phase II, Placebo-Controlled, Double-Blind Study of Paroxetine in Depressed Outpatients" },{ "PostingID": 2123, "Title": "GSK-29060/02/001", "Description": "A Double-Blind, Placebo-Controlled Study of Paroxetine in Depressed Outpatients" },{ "PostingID": 2124, "Title": "GSK-29060/03/001", "Description": "A Double-Blind, Imipramine- and Placebo-Controlled Study of Paroxetine in Depressed Outpatients" },{ "PostingID": 2125, "Title": "GSK-29060/07/001", "Description": "A Double-Blind Comparison of Paroxetine, Amitriptyline, and Placebo in Inpatients with Major Depressive Disorder with Melancholia" },{ "PostingID": 2126, "Title": "GSK-29060/009", "Description": "A Multicenter, Double-blind, Placebo-controlled Fixed-dose Evaluation of Four Doses of Paroxetine" },{ "PostingID": 2127, "Title": "GSK-29060/057", "Description": "A Double-blind comparative multicentre study of paroxetine plus supportive psychotherapy and psychotherapy alone in the prevention of recurrent suicidal behavior and episodes of intermittent brief depression" },{ "PostingID": 2128, "Title": "GSK-29060/106", "Description": "A double-blind comparative study of paroxetine and placebo in the treatment of episodes of intermittent brief depression (IBD)" },{ "PostingID": 2129, "Title": "GSK-29060/128", "Description": "A Multicenter, Randomized, Double-Blind, Placebo-Controlled Comparison of Paroxetine and Fluoxetine in the Treatment of Major Depressive Disorder" },{ "PostingID": 2130, "Title": "GSK-29060/251", "Description": "A Double-Blind, Randomized Trial of Paroxetine Versus Placebo In Patients With Depression Accompanied by Anxiety" },{ "PostingID": 2132, "Title": "GSK-26090/007", "Description": "A Double-Blind Placebo Controlled Study to Compare Paroxetine with Maprotiline in the Treatment of Depression" },{ "PostingID": 2133, "Title": "GSK-29060/276", "Description": "A double-blind study to investigate the efficacy, safety and tolerability of Paroxetine in the treatment of depression in comparison with placebo" },{ "PostingID": 2134, "Title": "GSK-29060/012_3", "Description": "A Study to Assess the Effectiveness and Tolerance of Paroxetine by Double-Blind Comparison with Placebo and Mianserin" },{ "PostingID": 2135, "Title": "GSK-29060/282", "Description": "A trial to assess the effectiveness and tolerance of paroxetine by double-blind comparison with placebo using a novel “shifted crossover” design" },{ "PostingID": 2136, "Title": "GSK-29060/327", "Description": "A double-blind, placebo-controlled, parallel group study of paroxetine in the treatment of dysthymia." },{ "PostingID": 2137, "Title": "GSK-29060/487", "Description": "A Double-Blind, Placebo Controlled Trial to Evaluate the Clinical Effects of Immediate Release Paroxetine and Controlled Release Paroxetine in the Treatment of Major Depression in Elderly Patients" },{ "PostingID": 2138, "Title": "GSK-29060/625", "Description": "A double-blind, placebo-controlled multi-centre study to evaluate the efficacy and tolerability of Paroxetine in the treatment of post-stroke depression." },{ "PostingID": 3161, "Title": "GSK-NKD20006", "Description": "An 8-Week, Randomized, Double-Blind, Placebo-Controlled, Multicenter, Fixed-Dose Study Comparing the Efficacy and Safety of GW597599B or Paroxetine to Placebo in Moderately to Severely Depressed Patients with Major Depressive Disorder" },{ "PostingID": 3563, "Title": "GSK-HTP109035", "Description": "A Randomised, Double-Blind, Parallel-Group, Placebo-Controlled Study Evaluating the Efficacy and Safety of GSK163090 in Subjects with Major Depressive Disorder" },{ "PostingID": 3705, "Title": "GSK-AK1113351", "Description": "Study AK1113351, a fixed dose study of 323U66 SR in the treatment of Major Depressive Disorder (MDD) - a multi-center, placebo-controlled, randomized, double-blind, parallel-comparison study" },{ "PostingID": 4238, "Title": "GSK-PCR112810", "Description": "A Randomized, Double-blind, Placebo Controlled Trial to Evaluate the Clinical Effects of Controlled Release Paroxetine in the Treatment of Major Depressive Disorder" },{ "PostingID": 4424, "Title": "GSK-PKI113009", "Description": "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" },{ "PostingID": 4738, "Title": "GSK-PKI108574", "Description": "A randomized, double blind, placebo controlled study to explore the antidepressant properties of P38a Kinase inhibitor GW856553X 15mg compared to PBO in Subjects with Major Depressive Disorder exhibiting symptoms of loss of energy and interest and psychomotor retardation, for a six week treatment period" },{ "PostingID": 4919, "Title": "GSK-29060/274", "Description": "A study to assess the effectiveness and tolerance of paroxetine by double-blind comparison with placebo" },{ "PostingID": 16074, "Title": "GSK-SCAA2010", "Description": "A Multicenter, Double–Blind, Placebo–Controlled, Flexible Dose (100–400mg) 10 Week Evaluation Of the Safety and Efficacy of LAMICTAL (Lamotrigine) in the Treatment of a Major Depressive Episode in Patients with Bipolar Disorder" },{ "PostingID": 16075, "Title": "GSK-SCAB2001", "Description": "A Multicenter, Double–Blind, Placebo–Controlled, Fixed Dose (50 or 200mg per day) 7 Week Evaluation of the Safety and Efficacy of LAMICTAL (Lamotrigine) in the Treatment of a Major Depressive Episode in Patients Suffering From Bipolar Disorder" },{ "PostingID": 20065, "Title": "GSK-PAR 29060.308 (HP/81/74A)", "Description": "Early clinical evaluation of a new antidepressant: A double-blind parallel study comparing paroxetine 30mg daily with amitriptyline 150mg daily" },{ "PostingID": 20066, "Title": "GSK-PAR 29060.309 HP/81/162A", "Description": "Early Clinical Evaluation of a New Antidepressant: A Double-Blind Parallel Study Comparing Paroxetine 30mg Daily with Amitriptyline 100mg Daily" },{ "PostingID": 20067, "Title": "GSK-PAR 29060.310 (HP 81/85A)", "Description": "Early Clinical Evaluation of a New Antidepressant: Double-Blind Parallel Study Comparing Paroxetine 30mg Daily with Amitriptyline 150mg Daily" },{ "PostingID": 20068, "Title": "GSK-PAR 29060.316 (HP/82/47A)", "Description": "Early Clinical Evaluation of a New Antidepressant: A Double-Blind Parallel Study Comparing Paroxetine 30mg Daily with Amitriptyline 150mg Daily" },{ "PostingID": 20069, "Title": "GSK-PAR 29060.314 (HP 82/134)", "Description": "Double Blind Parallel Study Comparing Paroxetine, 30mg Daily, and Amitriptyline, 150mg Daily, in Depressed Patients" },{ "PostingID": 20070, "Title": "GSK-PAR 29060/281", "Description": "A trial to assess the effectiveness and tolerance of paroxetine by double-blind comparison with amitriptyline in the treatment of depressed patients in General Practice" },{ "PostingID": 20071, "Title": "GSK-PAR 290 MDF 29060 1727 M", "Description": "A prospective, randomized, double-blind, multicentre study of the efficacy and tolerance of paroxetine versus clomipramine in the treatment of endogenous depression in the elderly" },{ "PostingID": 20072, "Title": "GSK-PAR MDED/29060/III/86/1728M291", "Description": "A Multi-Centre Double-Blind Study to Investigate the Safety and Efficacy of Paroxetine in Comparison with Clomipramine in the Treatment of Reactive Depression in Elderly Patients." },{ "PostingID": 20073, "Title": "GSK-MDF/29060/III/070/88/MC", "Description": "A multicentre, double-blind, parallel group, randomised dose study comparing the efficacy of paroxetine 20mg increasing to 30mg daily if there is insufficient response and clomipramine 60mg increasing to 75mg daily, in outpatients (age >60 years) with moderate depression according to feighner's criteria" },{ "PostingID": 20074, "Title": "GSK-MY-1001/BRL-029060/1/CPMS 069", "Description": "A Multicentre, Parallel Group Study to Compare the Efficacy and Tolerability of Paroxetine with Clomipramine in Elderly Patients." },{ "PostingID": 20075, "Title": "GSK-MY-060/BRL-029060/1.", "Description": "A multicentre, double-blind, randomised dose titration study comparing the pharmacodynamics and pharmacokinetics of paroxetine 20mg increasing to 30mg daily and amitriptyline 100mg increasing to 150mg daily in geriatric patients (age >65 years) with major depression." },{ "PostingID": 20076, "Title": "GSK-MY 1021/BRL 029060/1/CPMS/061", "Description": "A Double-blind Comparative Study Comparing Paroxetine b.d. (twice daily) with Fluoxetine b.d. (twice daily) in Geriatric Patients with Major Depression" },{ "PostingID": 20077, "Title": "GSK-PAR 29060/078", "Description": "A Multicentre Double Blind Study Comparing Paroxetine at a Dose of 20mg Increasing to 30mg Taken in the Morning and Amitriptyline 75mg Increasing to 150mg in Divided Doses in Adult Patients with Major Depressive Disorder" },{ "PostingID": 20078, "Title": "GSK-29060/063", "Description": "A double blind randomised trial comparing the effects on sleep of paroxetine 30mg daily and amitriptyline 150mg daily in patients with major depression." },{ "PostingID": 20079, "Title": "GSK-MY-1005/BRL-029060/1/CPMS-112", "Description": "A double-blind, multicentre study to compare the effectiveness and tolerance of paroxetine versus fluvoxamine in depressed patients" },{ "PostingID": 20081, "Title": "GSK-MY-1010/BRL029060/1/CPMS 079", "Description": "A double-blind comparative multicentre study comparing paroxetine b.d. (twice daily) with fluoxetine (Prozac®) b.d. (twice daily) in depressed patients" },{ "PostingID": 20082, "Title": "GSK-MY-059.073/29060/1", "Description": "A Multicentre, Double-blind Randomised Dose Titration Study Comparing the Efficacy and Safety Profiles of an Increasing Dose Regimen of Oral Paroxetine and Oral Amitriptyline in Adult Patients with Major Depression" },{ "PostingID": 20083, "Title": "GSK-MY-1055/BRL-029060/1/CPMS-245 PAR 245", "Description": "A Double-Blind, Multicentre Study in Primary Care Comparing Paroxetine and Clomipramine in Patients with Depression with Associated Anxiety" },{ "PostingID": 20085, "Title": "GSK-MY-1008/BRL-029060/2/CPMS-076", "Description": "The Effects of Paroxetine Versus Those of Maprotiline and Placebo on Fundamental Cognitive Functions, Perceptual-Motor Skills and Eye Movements in Depressed Patients" },{ "PostingID": 20087, "Title": "GSK-89", "Description": "Six-week, parallel, double-blind, randomized comparison of bupropion and trazodone (150-400mg/day) in outpatients" },{ "PostingID": 20088, "Title": "GSK-WELL 203", "Description": "A Multicenter Evaluation of the Safety and Efficacy of 150mg/day and 300mg/day of Bupropion HCl Sustained-Release Versus Placebo in Depressed Outpatients" },{ "PostingID": 20089, "Title": "GSK-Well 209", "Description": "The Safety and Efficacy of Wellbutrin Sustained Release and Sertraline in Depressed Outpatients" },{ "PostingID": 20090, "Title": "GSK-WELL 212", "Description": "A multicenter evaluation of the safety and efficacy of two flexible doses of WELLBUTRIN sustained-release versus placebo in depressed outpatients" },{ "PostingID": 20091, "Title": "GSK-WELL AK1A4002", "Description": "A Multicenter, Double-Blind, Placebo-Controlled Comparison of the Effects on Sexual Functioning of Wellbutrin (Bupropion HCl) Sustained Release and Sertraline in Outpatients with Moderate to Severe Recurrent Major Depression" },{ "PostingID": 20092, "Title": "GSK-WELL AK1A4001", "Description": "A Multicenter, Double-Blind, Placebo-Controlled Comparison of the Effects on Sexual Functioning of Wellbutrin (Bupropion HCI) Sustained Release and Sertraline in Outpatients with Moderate to Severe Recurrent Major Depression" },{ "PostingID": 20093, "Title": "GSK-WELL AK1A4007", "Description": "A Multicenter, Double-Blind, Placebo-Controlled Comparison of the Safety and Efficacy and Effects on Sexual Functioning of Wellbutrin (Bupropion HCl) Sustained Release (SR) and Fluoxetine in Outpatients with Moderate to Severe Recurrent Major Depression" },{ "PostingID": 20094, "Title": "GSK-WELL 205", "Description": "A multicenter dose-response evaluation of the safety and efficacy of bupropion HCI sustained-release versus placebo in depressed outpatients" },{ "PostingID": 20095, "Title": "GSK-WELL AK1A4006", "Description": "A Multicenter, Double-Blind, Placebo-Controlled Comparison of the Safety and Efficacy and Effects on Sexual Functioning of Wellbutrin (Bupropion HCl) Sustained Release (SR) and Fluoxetine in Outpatients with Moderate to Severe Recurrent Major Depression" },{ "PostingID": 20102, "Title": "GSK-LOC114589", "Description": "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" },{ "PostingID": 20175, "Title": "GSK-WELL AK140016", "Description": "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" }]