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    Summary
    EudraCT Number:2011-001520-37
    Sponsor's Protocol Code Number:KETECT
    National Competent Authority:Sweden - MPA
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2012-05-24
    Trial 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 ConcernedSweden - MPA
    A.2EudraCT number2011-001520-37
    A.3Full title of the trial
    Ketamine as an alternative to electroconvulsive therapy for treatment of major depressive disorder
    Ketamin som alternativ till ECT vid egentlig depression
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Ketamine as an alternative to electrocolvulsive therapy for treatment of major depressive disorder
    Ketamin som alternativ till elektrokonvulsiv terapi vid svår depression
    A.3.2Name or abbreviated title of the trial where available
    KETECT
    A.4.1Sponsor's protocol code numberKETECT
    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 SponsorSkåne University Hospital, Malmö
    B.1.3.4CountrySweden
    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 supportRegion Skåne
    B.4.2CountrySweden
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationSkåne University Hospital Malmö
    B.5.2Functional name of contact pointIda Ellerström
    B.5.3 Address:
    B.5.3.1Street AddressDpt of Anaesthesiology and intensive care medicine
    B.5.3.2Town/ cityMalmö
    B.5.3.3Post code20502
    B.5.3.4CountrySweden
    B.5.4Telephone number+46706601162
    B.5.5Fax number+4640336261
    B.5.6E-mailIda.ellerstrom@gmail.com
    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.2.5The 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 nameketamine
    D.3.2Product code ketamine
    D.3.4Pharmaceutical form Concentrate and solvent for solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous drip use (Noncurrent)
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Major depression disorder
    Egentlig depression
    E.1.1.1Medical condition in easily understood language
    Severe depression
    Svår depression
    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 18.0
    E.1.2Level PT
    E.1.2Classification code 10019063
    E.1.2Term Hallucination
    E.1.2System Organ Class 10037175 - Psychiatric disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 18.0
    E.1.2Level PT
    E.1.2Classification code 10013036
    E.1.2Term Diplopia
    E.1.2System Organ Class 10015919 - Eye disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 18.0
    E.1.2Level LLT
    E.1.2Classification code 10061243
    E.1.2Term Post procedural nausea
    E.1.2System Organ Class 100000004863
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 18.0
    E.1.2Level PT
    E.1.2Classification code 10047343
    E.1.2Term Vertigo CNS origin
    E.1.2System Organ Class 10029205 - Nervous system disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 18.0
    E.1.2Level LLT
    E.1.2Classification code 10015533
    E.1.2Term Euphoria
    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
    To compare the antidepressant effect of subanaesthetic ketamine to ECT.
    Att jämföra den antidepressiva effekten av subanestetisk infusion med ECT
    E.2.2Secondary objectives of the trial
    To further evaluate the safety of subanaesthetic ketamine regarding psychotic symptoms
    To investigate neurocognitive side effects of the two treatments, memory and executive functions in particular
    Att utvärdera säkerheten vid en subanestetisk dos av ketamin, gällandes psykotiska symptom.
    Att undersöka neurokognitiva bieffekter av de två behandlingarna, i synnerhet gällandes minne och exekutiva funktioner.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    ASA grade 1-3
    Age 18-65
    Major depressive episode according to DSM-IV
    Montgomery Asberg Depression Rating Scale (MADRS) ≥ 20
    Offered and accepted ECT
    Understands and speaks swedish
    Riskgrupp 1-3 enligt ASA
    Ålder 18 - 65 år vid tidpunkten för inklusion
    Uppfyllda diagnostiska kriterier för egentlig depression enligt DSM-IV
    Montgomery Asberg Depression Rating Scale (MADRS) ≥ 20
    Bedöms behöva, och accepterar, ECT
    Förmåga att förstå talad och skriven svenska

    E.4Principal exclusion criteria
    Reluctance to continued participation in the study
    Inability to adequately participate in the study
    Suspected serious adverse reaction
    Known / suspected allergy to drugs to be used in the study
    Comorbid psychiatric diagnosis that could interfere with treatment: primary psychotic disorder, personality disorder
    Habitual speech, hearing, memory, or cognitive difficulties
    Breastfeeding or anamnestic known / suspected pregnancy
    Known / suspected ongoing or recent (within 6 months) drug abuse
    Ongoing care of Compulsory Mental Care Act
    Hypovolemia, dehydration or heart disease, especially coronary artery disease (eg, congestive heart failure, myocardial ischemia, and myocardial infarction) due to the significant increase in myocardial oxygen consumption.
    Moderate hypertension and tachyarrhythmias
    Elevated cerebrospinal pressure and injuries or diseases of the CNS.
    Elevated intraocular pressure (e.g., glaucoma)
    Acute intermittent porphyria.
    Ongoing severe infection
    Ovilja till fortsatt deltagande i studien
    Oförmåga att adekvat medverka i studien
    Misstänkt allvarlig reaktion
    Känd/misstänkt allergi mot läkemedel som avses användas i studien
    Komorbid psykiatrisk diagnos som skulle kunna interferera med behandlingen: primär psykossjukdom, personlighetsstörning med kraftigt utagerande beteende.
    Habituella tal-, hörsel-, minnes-, eller kognitiva svårigheter
    Pågående amning eller anamnestiskt känd/misstänkt graviditet.
    Anamnestiskt känt/misstänkt pågående eller nyligen avslutat (inom 6 månader) drog-eller läkemedelsmissbruk
    Pågående vård enligt Lagen om psykiatrisk tvångsvård
    Hypovolemi, dehydrering eller hjärtsjukdom, särskilt koronarartärsjukdom (t ex kronisk hjärtinsufficiens, myokardischemi och hjärtinfarkt) p g a den betydande ökningen av myokardiell syrekonsumtion.
    Måttlig hypertension och takyarytmier.
    Förhöjt cerebrospinalt tryck samt skador eller sjukdomar i CNS.
    Förhöjt intraokulärt tryck (t ex glaukom) och vid undersökningar eller operationer i ögat, där en höjning av det intraokulära trycket är olämpligt.
    Akut intermittent porfyri.
    Pågående svår infektion
    E.5 End points
    E.5.1Primary end point(s)
    Antidepressive effect
    Antidepressiv effekt
    E.5.1.1Timepoint(s) of evaluation of this end point
    The assessment is made before, and 4-5 hours after the first treatment. Subsequent assessments are made 1 or 2 days after each treatment session, and within one week after remission. A major evaluation occurs after 6 treatments to determine continued participation in the study.
    Bedömning görs före och 4-5 timmar efter första behandlingen. Därefter sker de 1-2 dagar efter varje behandlingstillfälle, samt inom en vecka efter remission. En större utvärdering görs efter 6 behandlingstillfällen för att avgöra fortsatt deltagande i studien.
    E.5.2Secondary end point(s)
    Depressive symptoms
    Anxiety Symptoms
    Psychotic Symptoms
    cognition
    Suicide Risk
    Concerns and expectations
    Depressiva symtom
    Ångestsymtom
    Psykotiska symtom
    Kognition
    Suicidrisk
    Farhågor och förväntningar

    E.5.2.1Timepoint(s) of evaluation of this end point
    Depressive symptoms: before, and 4-5 hours after the first treatment, then 1 or 2 days after each treatment session, and within one week after remission, plus 2, 6, and 12 months after remission.
    Psychotic symptoms: before treatment, 1 and 4-5 hours after, and 1 or 2 days after the first treatment, the sixth treatment and the last treatment.
    Anxiety symptoms: same as for depressive symptoms.
    Cognition: Before the first treatment, after the 6th and the last treatment, and at 2, 6 and 12 months after remission.
    Suicide: In connection to each evaluation
    Concerns and expectations: Before the first treatment, and after the 6th and the last treatment.
    Depressiva symtom: före och 4-5 timmar efter första behandlingen. Därefter 1-2 dagar efter varje behandlingstillfälle, samt inom en vecka efter remission, plus 2, 6 och 12 månader efter remission.
    Psykotiska symtom: inför behandling, 1 och 4-5 timmar efter, samt 1-2 dagar efter 1:a, 6:e och sista behandlingen.
    Ångestsymtom: samtidigt som depressiva symptom
    Kognition: före första, efter 6e samt sista behandlingen, och vid 2, 6 och 12 månader efter remission.
    Suicidrisk: I samband med varje utvärdering
    Farhågor och förväntningar: före första och efter 6e samt sista behandlingen.
    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 Yes
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic Yes
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    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) Yes
    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 Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    Electroconvulsive therapy (standard treatment for depression) alone or combined with Ketalar
    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 concerned3
    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
    The end of study is individualized for each person. If the subject responds to treatment after 6 sessions the follow-up is 12 months in total.
    Slutet på studien är individuell för varje försöksperson. Om försökspersonen svarar på behandlingen efter 6 behandlingar är uppföljningstiden totalt 12 månader.
    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 days1
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 194
    F.1.3Elderly (>=65 years) No
    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 Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    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.4 Planned number of subjects to be included
    F.4.1In the member state194
    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)
    The plans for treatment of care after the subject has ended the participation in the trial is not different from the expected normal treatment of severe depression.
    Behandlingen och uppföljningen för patienterna efter deltagandet i studien skiljer sig inte från den förväntade normala behandlingen för egentlig depression.
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2014-02-14
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-06-19
    P. End of Trial
    P.End of Trial StatusOngoing
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