Predicting Response to Depression Treatment (PReDicT)

NCT02790970 | Completed DMC

• 1 other identifier: P1V-DEP-MD03
• Study Type: interventional
• Target: 913
• Locations: 5 countries
• Sites: 76

Brief Summary

Depression is a very common, serious and in some cases life-threatening condition, affecting around 350 million people globally. Approximately 11% of citizens in the European Union suffer from depression at some point in their lives. Depression is associated with significant socio-economic costs and has been predicted to become the greatest cause of disability worldwide by 2030 . In 2010 it was estimated that there were approximately 30 million patients with depression in Europe, with aggregated economic costs of approximately €92 billion . Improvements in managing the treatment of depression are urgently needed to improve patient outcomes, contain rising healthcare costs, improve workplace productivity and help to address global economic and societal challenges. While a range of effective antidepressant medications are available to treat depression, it takes 4-6 weeks after starting antidepressant treatment before a physician can detect whether the treatment is working. However, surprisingly, more than 50% of patients fail to respond to the first antidepressant treatment they are prescribed. Therefore, it often takes several months to identify an effective antidepressant treatment for the majority of patients with depression. During this time a patient's ability to work and function socially is severely impaired. Individuals may be absent from work for many weeks or months and this places a substantial burden on the economy and on healthcare resources.

Conditions

Depression

Outcome Measures

Primary Outcomes (1)

• Increase in proportion of depressed patients showing a response to treatment at week 8 when using the PReDicT Test to direct antidepressant treatment compared to treatment as usual as measured by the QIDS-SR-16

  QIDS-SR-16 is a standard questionnaire "The Quick Inventory of Depressive Symptomatology" (16-Item) (Self-Report). This covers questions on falling asleep, sleep during the night, waking up , sleeping too much, feeling sad ,appetite, weight, concentration , how they view themselves, thoughts of death and suicide, general interests, energy levels, feeling slowed down , feeling restless. These will be compared at baseline and after 8 weeks of treatment.

  8 weeks

Secondary Outcomes (16)

• Compare the change from baseline in QIDS-SR-16 scores

  8 weeks

• Increase in proportion of depressed patients showing a response to treatment at week 8 when using the PReDicT Test to direct antidepressant treatment compared to treatment as usual as measured by a reduction of >50% in the MADRS score

  8 weeks

• Increase in proportion of depressed patients showing remission from depression at week 8 when using the PReDicT Test to direct antidepressant treatment compared to treatment as usual as measured by a QIDS-SR-16 score <=5

  8 Weeks

• Compare changes in baseline of the QIDS-SR-16 score

  12 weeks

• Compare changes in baseline of the QIDS-SR-16 score

  24 weeks and 48 weeks

Study Arms (2)

PReDicT Test

EXPERIMENTAL

To determine whether use of the PReDicT Test to direct antidepressant treatment results in an increased proportion of depressed patients showing a response to treatment at week 8

Device: PReDicT Test

Treatment as usual

PLACEBO COMPARATOR

Treat patients as usual without using the predict test to determine treatment.

Other: Treatment as Usual

Interventions

PReDicT Test DEVICE

PReDicT Test, when completed 7-9 days after starting antidepressant treatment, is able to predict a patient's subsequent response to that antidepressant treatment 4-6 weeks later

PReDicT Test

Treatment as Usual OTHER

Patients treated by the clinician conventionally using signs and symptoms to determine treatment changes or medication changes.

Treatment as usual

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female aged between 18 and 70 inclusive.
• Diagnosed with a depressive episode by a physician (either first episode or recurrent) and requiring treatment with a selective serotonin reuptake inhibitor (SSRI) medication (excluding fluoxetine).
• Prescribed an SSRI by a physician for the treatment of depression within 7 days prior to Visit 1, but has not yet started taking medication.
• Is intending to start SSRI treatment within 7 days of Visit 1.

You may not qualify if:

• Previous history of mania.
• Is currently taking an antidepressant medication or has stopped antidepressant treatment within 2 weeks prior to Visit 1.
• Requires immediate referral to alternative mental health services (e.g. where a patient seen in primary care is referred to secondary care services).
• Presents to a physician with significant current suicidal intent requiring enhanced care.

Sponsors & Collaborators

• P1vital Products Limited: lead

Study Sites (76)

Centre Hospitalier Sainte-Anne

Paris, 75014, France

Location

Praxis Dr. Hofmann

Aschaffenburg, 63739, Germany

Location

Praxis Wagner

Aschaffenburg, 63741, Germany

Location

Praxis Dunkel

Frankfurt am Main, 60389, Germany

Location

Agaplesion Markus Krankenhaus

Frankfurt am Main, 60431, Germany

Location

Dept of Psychiatry, Outpatient Clinic, University Hospital

Frankfurt am Main, 60528, Germany

Location

Praxis Dr. Körner

Frankfurt am Main, 65934, Germany

Location

Praxis Dr. Gunreben

Kitzingen, 97318, Germany

Location

Praxis Dr. Boreatti

Lohr, 97816, Germany

Location

Praxis Dr. Vondung

Mühlheim, 63165, Germany

Location

Praxis Bayer

Offenbach, 63065, Germany

Location

Praxis Dr. Frühauf

Offenbach, 63069, Germany

Location

Praxis Schell

Offenbach, 63071, Germany

Location

Praxis Dr. Rost

Randersacker, 97236, Germany

Location

Praxis Dr. Meesmann

Schweinfurt, 97421, Germany

Location

Praxis Habermeyer

Veitshöchheim, 97209, Germany

Location

Schloss Werneck

Werneck, 97440, Germany

Location

Department of Psychiatry

Würzburg, 97070, Germany

Location

Medizinisches Studienzentrum (MSZ)

Würzburg, 97070, Germany

Location

Praxis Dr. Heine

Würzburg, 97070, Germany

Location

Praxis Dr. Kropp

Würzburg, 97070, Germany

Location

Praxis Dr. Reimann

Würzburg, 97070, Germany

Location

Gezondheidscentrum de Keijzer

Amsterdam, 1018 PR, Netherlands

Location

Gezondheidscentrum Borgerstraat

Amsterdam, 1053 PW, Netherlands

Location

Gezondheidscentrum De Vaart

Amsterdam, 1060 SZ, Netherlands

Location

GGZ inGeest

Amsterdam, 1062 HN, Netherlands

Location

Prezens - bGGZ

Amsterdam, 1062 HN, Netherlands

Location

Gezondheidscentrum Osdorp

Amsterdam, 1069 DA, Netherlands

Location

Huisartsenpraktijk Houben en Zonneveld

Amsterdam, 1078 GE, Netherlands

Location

Huisartsenpraktijk Land

Amsterdam, 1078 GE, Netherlands

Location

Huisartsenpraktijk De Grote Rivieren

Amsterdam, 1079 BG, Netherlands

Location

Dept of Psychiatry, Vumc

Amsterdam, 1081 BT, Netherlands

Location

Universitaire Huisartsenpraktijk VUmc

Amsterdam, 1081 HV, Netherlands

Location

Huisartsenpraktijk MC Gelderlandplein

Amsterdam, 1082 LD, Netherlands

Location

Huisartsenpraktijk Buitenhof

Amsterdam, 1090 HA, Netherlands

Location

Gezondheidscentrum Venserpolder

Amsterdam, 1102 VL, Netherlands

Location

Gezondheidscentrum Klein-Gooioord

Amsterdam, 1103 TW, Netherlands

Location

Gezondheidscentrum Gein

Amsterdam, 1106 MH, Netherlands

Location

Gezondheidscentrum Reigersbos

Amsterdam, 1107 GA, Netherlands

Location

Gezondheidscentrum Nellestein

Amsterdam, 1108 HE, Netherlands

Location

Gezondheidscentrum Diemen-Noord

Amsterdam, 1111 ST, Netherlands

Location

De Hoofdlijn

IJmuiden, 1971 BS, Netherlands

Location

CAP Barceloneta

Barcelona, 08003, Spain

Location

Hospital del Mar

Barcelona, 08003, Spain

Location

CAP Vila Olímpica

Barcelona, 08005, Spain

Location

Centre Fòrum

Barcelona, 08019, Spain

Location

CAP Larrard

Barcelona, 08024, Spain

Location

St Chad's Surgery

Midsomer Norton, Bath, BA3 2UH, United Kingdom

Location

The Boathouse Surgery

Pangbourne, Berkshire, RG87DP, United Kingdom

Location

Carlisle Healthcare

Carlisle, Cumbria, CA1 1DG, United Kingdom

Location

The Limes Medical Centre

Alfreton, Derbyshire, DE55 7DW, United Kingdom

Location

Burbage Surgery

Burbage, Leicestershire, LE10 2SE, United Kingdom

Location

Lindum Medical Practice

Lincoln, Lincolnshire, LN2 2JP, United Kingdom

Location

Nettleham Medical Practice

Nettleham, Lincoln, LN2 2RS, United Kingdom

Location

Welton Family Health Centre

Welton, Lincoln, LN2 3JH, United Kingdom

Location

Lakeside Surgery

Corby, Northamptonshire, NN17 2UR, United Kingdom

Location

Danetre Medical Practice

Daventry, Northamptonshire, NN11 4DY, United Kingdom

Location

Earls Barton Medical Centre

Earls Barton, Northamptonshire, NN6 0EU, United Kingdom

Location

Rothwell and Desborough Healthcare Group

Rothwell, Northamptonshire, NN14 6JQ, United Kingdom

Location

Albany House Medical Centre

Wellingborough, Northamptonshire, NN8 4RW, United Kingdom

Location

Atherstone Surgery

Atherstone, Warwickshire, CV9 1EU, United Kingdom

Location

Sherbourne Medical Centre

Royal Leamington Spa, Warwickshire, CV32 4RA, United Kingdom

Location

The Porch Surgery

Corsham, Wiltshire, SN13 9DL, United Kingdom

Location

Adcroft Surgery

Trowbridge, Wiltshire, BA14 8QA, United Kingdom

Location

Bradford Road Medical Centre

Trowbridge, Wiltshire, BA14 9AR, United Kingdom

Location

Westbury Group Medical Practice

Westbury, Wiltshire, BA13 3FQ, United Kingdom

Location

The Pulteney Practice

Bath, BA2 4BY, United Kingdom

Location

Newton Place Surgery

Faversham, ME13 8FH, United Kingdom

Location

Thurmaston Health Centre

Leicester, LE4 8EA, United Kingdom

Location

Birchwood Medical Practice

Lincoln, LN6 0QQ, United Kingdom

Location

Lincoln University Health Care

Lincoln, United Kingdom

Location

Leicester Terrace

Northampton, NN2 6AL, United Kingdom

Location

Danes Camp Practice

Northampton, NN4 0NY, United Kingdom

Location

Family Medical Centre

Nottingham, NG3 2FW, United Kingdom

Location

University of Nottingham Health Service - Cripps Health Centre

Nottingham, NG7 2QW, United Kingdom

Location

South Oxford Health Centre

Oxford, OX1 4RP, United Kingdom

Location

Related Publications (4)

• World Health Organization, The Global Burden of Disease: 2004 update. nDeneva, World Health Organization, 2008.

  RESULT

• Wittchen HU, Jacobi F, Rehm J, Gustavsson A, Svensson M, Jonsson B, Olesen J, Allgulander C, Alonso J, Faravelli C, Fratiglioni L, Jennum P, Lieb R, Maercker A, van Os J, Preisig M, Salvador-Carulla L, Simon R, Steinhausen HC. The size and burden of mental disorders and other disorders of the brain in Europe 2010. Eur Neuropsychopharmacol. 2011 Sep;21(9):655-79. doi: 10.1016/j.euroneuro.2011.07.018.

  PMID: 21896369 RESULT

• Rush AJ. STAR*D: what have we learned? Am J Psychiatry. 2007 Feb;164(2):201-4. doi: 10.1176/ajp.2007.164.2.201. No abstract available.

  PMID: 17267779 RESULT

• Kingslake J, Dias R, Dawson GR, Simon J, Goodwin GM, Harmer CJ, Morriss R, Brown S, Guo B, Dourish CT, Ruhe HG, Lever AG, Veltman DJ, van Schaik A, Deckert J, Reif A, Stablein M, Menke A, Gorwood P, Voegeli G, Perez V, Browning M. The effects of using the PReDicT Test to guide the antidepressant treatment of depressed patients: study protocol for a randomised controlled trial. Trials. 2017 Nov 23;18(1):558. doi: 10.1186/s13063-017-2247-2.

  PMID: 29169399 DERIVED

MeSH Terms

Conditions

Depression

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Study Officials

• Mike Browning

  P1vital Limited

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 30, 2016
• First Posted: June 6, 2016
• Study Start: May 1, 2016
• Primary Completion: November 30, 2018
• Study Completion: September 1, 2019
• Last Updated: March 5, 2020

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will not share

Locations

NL (20); ES (5); FR (1); DE (21); GB (29)