Augmenting treatment for chronic depression with ketamine
Pharmacologic Treatment Augmentation in Chronic Depression "Randomized, Controlled, Double Blinded, Phase II Study"
PHASE2 · University Hospital Tuebingen · NCT06410599
This study is testing if adding ketamine to regular treatment can help adults with chronic depression who haven't found relief from other medications or therapy.
Quick facts
| Phase | PHASE2 |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years to 64 Years |
| Sex | All |
| Sponsor | University Hospital Tuebingen (other) |
| Locations | 2 sites (Tübingen, Baden-Würtemberg and 1 other locations) |
| Trial ID | NCT06410599 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the effectiveness of ketamine as an augmentation therapy for patients with chronic depression who have not responded to at least two different antidepressants and have undergone at least 12 sessions of psychotherapy. Participants aged 18 to 64 will be screened through a clinical interview, physical examination, and medical tests to ensure they meet the inclusion criteria. Those who qualify will be randomly assigned to one of three treatment groups: ketamine plus treatment as usual, ketamine plus cognitive behavioral analysis system of psychotherapy (CBASP), or a placebo group. The study seeks to determine if the combination of ketamine with psychotherapy can provide significant relief from depressive symptoms.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 to 64 with chronic depression who have not responded to at least two different classes of antidepressants and have undergone significant psychotherapy without improvement.
Not a fit: Patients who have not reached therapy resistance stage 2 or those with acute depressive episodes lasting less than two years may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could offer a new therapeutic option for patients suffering from chronic depression who have not benefited from traditional antidepressant therapies.
How similar studies have performed: Other studies have shown promising results with ketamine as a treatment for depression, indicating that this approach may be effective.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age: 18 to 64 years at the time of study inclusion. * Diagnosis of chronic depression: recurrent depressive disorder, severe or moderate episodes (no full remission between the episodes according to DSM-IV-TR (Falkai et al., 2015) \[no distinct depressive symptoms for at least two months\]) or acute depressive episode lasting two or more years * Treatment resistance stage 2 according to (Thase and Rush, 1997): Patient's symptoms fulfil the criteria of chronic depression listed above even after at least two appropriate treatment attempts with two antidepressant medicaments from two different effect categories * Patient's symptoms fulfil the criteria of chronic depression listed above even after executing at least 12 sessions of psychotherapeutic treatment (psychoanalysis, depth psychology-based psychotherapy or cognitive behaviour therapy) * Understand and voluntarily sign an informed consent document prior to any study related assessments/ procedures. * Able to adhere to the study visit schedule and other protocol requirements. * Females of childbearing potential (FCBP) must agree to utilize two reliable forms of contraception simultaneously or practice complete abstinence from heterosexual contact from study start until 28 days after the last infusion. * Males must agree to use a latex condom during any sexual contact with FCBP from the first infusion until 65 days after the last infusion, even if the person has undergone a successful vasectomy to refrain from donating semen or sperm from the first infusion until 65 days after the last infusion. * All subjects must agree to refrain from donating blood from the first infusion until 28 days after last infusion. * All subjects must agree not to share medication. Exclusion Criteria: * Acute substance misuse as primary diagnosis (assessed by the Structured Clinical Interview for DSM-V (SKID, Wittchen et al., 1997)) * Neurologic disorders: Stroke, cerebral ischemia, tumor, cerebral infection, autoimmune disease (according to clinical interview) * Disorders with increase of intracranial pressure, e. g. due to head injury (according to clinical interview) * Circulatory disturbance in the brain (according to clinical interview) * Pregnant or lactating females * Participation in any clinical study or having taken any investigational therapy, which would interfere with the study's primary end point * Epilepsy (according to clinical interview) * History of hypersensitivity to an investigational medicinal product or to any drug with similar chemical structure or to any excipient present in the pharmaceutical form of the investigational medicinal product (according to clinical interview) * Pre-treatment with ketamine hydrochloride (Ketamin Inresa 2 ml) and/ or - CBASP (according to clinical interview) * Not or insufficiently treated hypertonia (subject will be excluded if repeated measures (3 times/ day) show values greater than 150 mmHg systolic or 100 mmHg diastolic blood pressure or if a lifetime diagnosis of hypertonia is reported) * Not or insufficiently treated hyperthyroidism (according to clinical interview) * Heartache due to insufficient blood circulation (unstable angina pectoris) or heart muscle infarct (myocardia infarct) during the last six months (according to clinical interview) * Increased intraocular pressure (glaucoma) and perforating eye injury (according to clinical interview) * Interventions in the area of the upper respiratory passages (according to clinical interview)
Where this trial is running
Tübingen, Baden-Würtemberg and 1 other locations
- Universitätsklinikum Tübingen - Klinik für Psychiatrie und Psychotherapie — Tübingen, Baden-Würtemberg, Germany (RECRUITING)
- Universitätsklinikum Jena - Klinik für Psychiatrie und Psychotherapie — Jena, Thuringia, Germany (RECRUITING)
Study contacts
- Principal investigator: Martin Walter, Prof. Dr. — Universitätsklinikum Jena - Klinik für Psychiatrie und Psychotherapie
- Study coordinator: Martin Walter, Prof. Dr.
- Email: martin.walter@med.uni-jena.de
- Phone: +493641 9390101
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Major Depressive Disorder, Ketamine, CBASP, Augmentation, Combination therapy, Chronic depression, MDD