Oral ketamine for treating depressio

Phase 1

Conditions: Treatment resistant major depressive disorder
Therapeutic area: Psychiatry and Psychology [F] - Mental Disorders [F03]

Registration Number: EUCTR2015-003957-16-NL

Lead Sponsor: niversity Medical Centre Groningen

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: Not specified

Inclusion Criteria

In order to be eligible to participate in this study, a subject must meet all the following criteria:
- Male or female, age range: 18 to 80 years;
- Signed informed consent;
- Good understanding of spoken and written Dutch;
- DSM-5 diagnosis of MDD, first or recurrent episode, ascertained by the Mini International Neuropsychiatry Interview (MINI-plus);
- TRD, defined as nonresponse to at least 3 different classes of antidepressants during lifetime, all given in an adequate dose (i.e. defined daily dose) for at least 4 weeks;
- At least moderately severe depression, defined by a score higher than 18 on HDRS17;
- Current treatment with an officially approved antidepressant medicine.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 118
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 10

Exclusion Criteria

A potential subject who meets any of the following criteria will be excluded from participation:
- Bipolar depression or depression with psychotic features, according to the DSM-5;
- Previous or comorbid schizophrenia spectrum or other psychotic disorder according to the DSM-5, not including MDD with psychotic features;
- Comorbid severe personality disorder according to the DSM-5, that is the main reason for treatment;
- Previous or comorbid moderate or severe dependence of alcohol or drugs according to the DSM-5, not including tobacco-related and caffeine-related disorders;
- Recent (within the last 4 weeks) or current use of cannabis or any other non-prescribed psychoactive compounds, including Saint John’s wort;
- Relevant neurological disorder, such as dementia or epilepsy;
- Recent (within the last 4 weeks) change of antidepressant treatment;
- ECT sessions or any other antidepressant treatment change planned for the period of the study;
- Active suicidal intent, defined by scores higher than 2 on HDRS17 for suicidal ideation;
- (Suspected) pregnancy, insufficient contraception or lactation. If there is any doubt, a pregnancy test is performed;
- Recent (within the last 4 weeks) or current use of benzodiazepine and benzodiazepine-like agents (zolpidem, zopiclone) in excess of 2 mg lorazepam or an equivalent per day;
- Recent (within the last 4 weeks) or current use of somatic medication that commonly affects mood, like oral corticosteroids;
- Presence of any contra-indication for ketamine use, such as increased intracranial pressure, recent myocardial infarction or other relevant cardiac problems, severe hypertension, severe hyperthyroidism, severe liver problems, severe kidney problems, or the use of medication that ketamine interacts with on a major level, such as monoamine oxidase inhibitors;
- Vision or hearing problems that cannot be corrected and that interfere with the ability to comply with treatments and/or assessments;
- Mental incompetence to provide informed consent, based on the judgment of the general practitioner or treating psychiatrist of the participant;
- Inability to comply with treatments and/or assessments, based on the judgment of the general practitioner or treating psychiatrist of the participant.