Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   43871   clinical trials with a EudraCT protocol, of which   7290   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Print Download

    Summary
    EudraCT Number:2011-005476-41
    Sponsor's Protocol Code Number:MMHSCT1096
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2012-05-01
    Trial results View results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedUK - MHRA
    A.2EudraCT number2011-005476-41
    A.3Full title of the trial
    Ketamine augmentation of ECT to improve outcomes in depression
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Ketamine augmentation of (meaning addition to) ECT to improve outcomes in depression.
    A.3.2Name or abbreviated title of the trial where available
    Ketamine-ECT Study
    A.4.1Sponsor's protocol code numberMMHSCT1096
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorManchester Mental Health and Social Care Trust
    B.1.3.4CountryUnited Kingdom
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportEfficacy and Mechanism Evaluation programme
    B.4.2CountryUnited Kingdom
    B.4.1Name of organisation providing supportNational Health Service
    B.4.2CountryUnited Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationUniversity of Manchester
    B.5.2Functional name of contact pointProf Ian Anderson
    B.5.3 Address:
    B.5.3.1Street AddressRoom G809, Stopford Building, Neuroscience and Psychiatry Unit
    B.5.3.2Town/ cityOxford Road, Manchester
    B.5.3.3Post codeM13 9PT
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number0161 275 7428
    B.5.5Fax number0161 275 7429
    B.5.6E-mailian.anderson@manchester.ac.uk
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name Ketalar
    D.2.1.1.2Name of the Marketing Authorisation holderPfizer Limited
    D.2.1.2Country which granted the Marketing AuthorisationUnited Kingdom
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameKetalar
    D.3.4Pharmaceutical form Solution for injection/infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous bolus use (Noncurrent)
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNketamine hydrochloride
    D.3.9.1CAS number 1867-66-9
    D.3.9.3Other descriptive name(RS)-2-(2-Chlorophenyl)-2-(methylamino)cyclohexanone hydrochloride
    D.3.9.4EV Substance CodeAS1
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboSolution for injection/infusion
    D.8.4Route of administration of the placeboIntravenous bolus use (Noncurrent)
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Depressive disorder requiring treatment with electroconvulsive treatment (ECT)
    E.1.1.1Medical condition in easily understood language
    Depression requiring treatment with electroconvulsive treatment (ECT)
    E.1.1.2Therapeutic area Psychiatry and Psychology [F] - Mental Disorders [F03]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level PT
    E.1.2Classification code 10012378
    E.1.2Term Depression
    E.1.2System Organ Class 10037175 - Psychiatric disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Ketamine vs saline treatment will reduce ECT-induced cognitive impairments as measured by being able to learn new verbal information (anterograde verbal memory), remember personal events from their past (autobiographical memory) and saying the names of objects fluently (verbal fluency)
    E.2.2Secondary objectives of the trial
    CLINICAL HYPOTHESES 1) Four months after ECT a significant difference between ketamine and saline groups in cognitive function will remain only for autobiographical memory 2). Ketamine vs saline treatment will result in a greater decrease in depression scores after 4 treatments 3) Compared with saline, patients receiving ketamine will need fewer ECT treatments to achieve remission MECHANISTIC HYPOTHESES 4) Ketamine vs saline, treatment will increase frontal cortex activation as measured by brain imaging (fNIRS and fMRI) in response to a verbal fluency, but not a working memory task, and this will relate to group differences in task performance. 5) Ketamine vs saline treatment will result in stronger frontal cortex-hippocampal connections (measured by functional connectivity analysis with fMRI with the verbal fluency task). 6) Ketamine treatment vs saline treatment will be associated with a relative increase in frontal brain blood oxygenation which will be related to differences
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Patient Inclusion criteria: 1.Male or female aged 18 years and above; 2.Current DSM-IV diagnosis of a major depressive episode, moderate or severe as part of unipolar or bipolar disorder mood disorder diagnosed by the Mini International Neuropsychiatric Interview (MINI) 3.American Society of Anaesthesiologists (ASA) score (excluding mental health considerations in the scoring) of 1, 2 or stable 3, and judged as suitable to receive ketamine by an anaesthetist; 4.Verbal IQ ≥ 85, sufficiently fluent in English to validly complete neuropsychological testing; 5.Capacity to give informed consent; 6.Willing to undertake neuropsychological testing as part of the study. Healthy control inclusion criteria: 1.Aged 18 years or more; 2.Currently psychiatrically well, confirmed through MINI interview and no current psychotropic medication; 3.In good physical health.
    E.4Principal exclusion criteria
    Patient exclusion criteria: 1.DSM-IV diagnosis of a primary psychotic or schizoaffective disorder, current primary obsessive compulsive disorder or anorexia nervosa; 2.History of drug or alcohol dependence (DSM-IV criteria) within the last year; 3.ECT in last 6 months (to avoid confounding the assessment of cognitive outcomes) or has previously received ECT in the current trial; 4.Known hypersensitivity or contraindication to ketamine or excipients in the injection; including significant cardiovascular disease, uncontrolled hypertension, glaucoma, cirrhosis or significant liver impairment; 5.Known hypersensitivity or contraindication to concomitant medications used for ECT: thiopentone (thiopental), propofol and suxamethonium or excipients in the injections; 6.Evidence of organic brain disease including dementia, neurological illness or injury, or medical illness which may significantly affect neuropsychological function; 7.Detained under the Mental Health Act (1983 as amended 2007) or unable to give informed consent; 8.Pregnancy, or at risk of pregnancy and not taking adequate contraception, breastfeeding; 9.Score ≤ 24 on the Mini Mental State Examination (MMSE); 10.In the subgroup receiving MRI based investigation (fMRI, MRS and ASL) contraindication to MRI (eg metal implants or foreign bodies such as from a surgical implant, accident or injury). Control exclusion Criteria: 1.Personal history of psychiatric disorder, as revealed by MINI interview; 2.First degree family history of major psychiatric illness requiring treatment; 3.Significant physical illness including organic brain disease, neurological illness or injury that could interfere with interpretation of results; 4.Psychotropic medication or other medication that could interfere with interpretation of results; 5.Score ≤ 24 on the Mini Mental State Examination (MMSE); 6.In the subgroup receiving MRI based investigation (fMRI, MRS and ASL) contraindication to MRI (eg metal implants or foreign bodies such as from a surgical implant, accident or injury).
    E.5 End points
    E.5.1Primary end point(s)
    Change in memory between baseline and end of ECT course measured by: Hopkins Verbal Learning Test – Revised (HVLT-R) Autobiographical Memory Interview - short form (AMI-SF) Controlled Oral Word Association Test (COWAT)
    E.5.1.1Timepoint(s) of evaluation of this end point
    Changes between baseline and end of ECT course
    E.5.2Secondary end point(s)
    A Changes in memory between baseline and one and 4 month follow up measured by: Hopkins Verbal Learning Test – Revised (HVLT-R) Autobiographical Memory Interview - short form (AMI-SF) Controlled Oral Word Association Test (COWAT) B Cognitive changes between baseline and end of ECT, and one and 4 month follow up measured by: Medical College of Georgia Complex Figure Test (MCG complex figure test) Digit span Self-reported Global Self Evaluation of Memory (GSE-My) C Symptoms ratings measured from baseline to after 4 ECT treatments, at end of ECT and at one and 4 month follow up measured by: Mongomery Asberg Depression Rating Scale Clinical Anxiety Scale Brief Psychiatric Rating Scale Remission at end of ECT (MADRS ≤10) Number of ECT treatments to achieve remission Response at end of ECT (≥ 50% decrease in MADRS from baseline) Clinical Global Impression – Severity and Improvement (CGI-S, CGI-I) Quick Inventory of Depressive Symptomatology - Self Report (QIDS-SR) Proportion significantly worsening after end of ECT (MADRS increase of ≥4 points + CGI-S increase of ≥1 point to CGI-S ≥3 compared with assessment at end of ECT. D Mechanistic outcomes in subgroups between baseline and end of ECT, and at one and 4 month follow up: Haemodynamic response to verbal fluency and working memory tasks using fNIRS Tissue oxygenation index measured by NIRS E Mechanistic outcomes in subgroups between baseline and end of ECT: Haemodynamic response to verbal fluency and working memory tasks using fMRI Brain glutamate concentration measured by magnetic resonance spectroscopy Frontal blood flow measure by arterial spin labelling fMRI
    E.5.2.1Timepoint(s) of evaluation of this end point
    A: Changes between baseline and one and 4 month follow up. B: Changes between baseline and end of ECT, and one and 4 month follow up. C and D: Baseline, after 4 ECT treatments, at end of ECT and at one and 4 month follow up. E: Baseline and end of ECT
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    Mechanistic using brain imaging
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) Yes
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind Information not present in EudraCT
    E.8.1.4Double blind Information not present in EudraCT
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other Yes
    E.8.1.7.1Other trial design description
    Anesthetist giving drug not blind, ECT/clinical team + assessors blind
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned6
    E.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.7Trial has a data monitoring committee Yes
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    E.8.9.1In the Member State concerned months1
    E.8.9.1In the Member State concerned days29
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months1
    E.8.9.2In all countries concerned by the trial days29
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1Number of subjects for this age range: 0
    F.1.1.1In Utero No
    F.1.1.1.1Number of subjects for this age range: 0
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.2.1Number of subjects for this age range: 0
    F.1.1.3Newborns (0-27 days) No
    F.1.1.3.1Number of subjects for this age range: 0
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.4.1Number of subjects for this age range: 0
    F.1.1.5Children (2-11years) No
    F.1.1.5.1Number of subjects for this age range: 0
    F.1.1.6Adolescents (12-17 years) No
    F.1.1.6.1Number of subjects for this age range: 0
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 90
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 90
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.3.3.7.1Details of other specific vulnerable populations
    Subjects with mental disorder (depression)
    F.4 Planned number of subjects to be included
    F.4.1In the member state180
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 180
    F.4.2.2In the whole clinical trial 180
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    As ketamine augmentation will only be given during the course of ECT continued provision of the intervention after the research does not apply. If the study is successful then ketamine, which is readily available, may become a routine part of ECT treatment.
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    G.4.1Name of Organisation NONE
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2012-05-18
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-01-25
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2015-09-30
    For support, Contact us.
    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

    European Medicines Agency © 1995-Fri May 03 03:15:26 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA