E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Major depression disorder |
Egentlig depression |
|
E.1.1.1 | Medical condition in easily understood language |
Severe depression |
Svår depression |
|
E.1.1.2 | Therapeutic area | Psychiatry and Psychology [F] - Mental Disorders [F03] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 18.0 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10019063 |
E.1.2 | Term | Hallucination |
E.1.2 | System Organ Class | 10037175 - Psychiatric disorders |
|
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 18.0 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10013036 |
E.1.2 | Term | Diplopia |
E.1.2 | System Organ Class | 10015919 - Eye disorders |
|
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 18.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10061243 |
E.1.2 | Term | Post procedural nausea |
E.1.2 | System Organ Class | 100000004863 |
|
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 18.0 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10047343 |
E.1.2 | Term | Vertigo CNS origin |
E.1.2 | System Organ Class | 10029205 - Nervous system disorders |
|
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 18.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10015533 |
E.1.2 | Term | Euphoria |
E.1.2 | System Organ Class | 10037175 - Psychiatric disorders |
|
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main 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.2.2 | Secondary 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.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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.4 | Principal 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.5.1 | Primary end point(s) |
Antidepressive effect |
Antidepressiv effekt |
|
E.5.1.1 | Timepoint(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.5.2 | Secondary 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.5.2.1 | Timepoint(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.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | Yes |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | Yes |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | Yes |
E.8.2.3.1 | Comparator description |
Electroconvulsive therapy (standard treatment for depression) alone or combined with Ketalar |
|
E.8.2.4 | Number of treatment arms in the trial | 2 |
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.8.4.1 | Number of sites anticipated in Member State concerned | 3 |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial 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.8.9.1 | In the Member State concerned years | 3 |
E.8.9.1 | In the Member State concerned months | 1 |
E.8.9.1 | In the Member State concerned days | 1 |