Orale ketamine als aanvullende behandeling bij patiënten met een therapieresistente depressie
- Conditions
- <p>Treatment-resistant major depressive disorder, therapie resistente depressie</p>
- Registration Number
- NL-OMON24824
- Lead Sponsor
- MCG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 128
Inclusion Criteria
Male or female, age range: 18 to 80 years;
- Signed informed consent;
Exclusion Criteria
- 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;
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The primary objective of this trial is to examine the antidepressant efficacy of oral S-ketamine augmentation in patients with TRD. This will be measured by the following main study endpoints at the end of treatment: 1) change in symptom severity, expressed as a change in total score on the HDRS17; 2) response, defined as ¡Ý 50% decrease in total score on the HDRS17; 3) partial response, defined as 25-49% decrease in total score on the HDRS17.</p>
- Secondary Outcome Measures
Name Time Method