NCT06410599 Pharmacologic Treatment Augmentation in Chronic Depression
| NCT ID | NCT06410599 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | University Hospital Tuebingen |
| Condition | Major Depressive Disorder |
| Study Type | INTERVENTIONAL |
| Enrollment | 60 participants |
| Start Date | 2024-04-29 |
| Primary Completion | 2026-05 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 60 participants in total. It began in 2024-04-29 with a primary completion date of 2026-05.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
To enroll in this clinical trial, prospective participants must meet stringent criteria. The participants need to fall within the age range of 18 to 64 and exhibit chronic depression at therapy resistance stage 2. This stage signifies that the participants have undergone unsuccessful treatment with at least two different antidepressants, despite adequate dosage and duration. Moreover, the participants should have engaged in at least 12 sessions of psychotherapy without experiencing significant relief from depressive symptoms. Additionally, participants must demonstrate the cognitive capacity to provide informed consent. Upon expressing interest in the study and consenting to participate, individuals undergo a thorough screening process. This screening encompasses a comprehensive clinical interview to assess medical and psychiatric history, as well as various medical tests. These tests include physical examinations, blood draws (which may include pregnancy tests for female participants), and electrocardiograms (ECGs) to evaluate heart function. Following the screening, participants are randomly assigned to one of three different treatment groups (Ketamine +TAU; Ketamine+CBASP, Placebo+CBASP). The study protocol involves a combination of psychotherapeutic treatment and either ketamine infusions or placebo. Throughout the study period, participants are subject to regular data collection, including psychological assessments, blood samples, and magnetic resonance imaging (MRI) scans. Participants' responses to treatment, as well as any changes in symptoms or side effects, are closely monitored. After completing the study, participants are offered follow-up therapy as part of standard care. MRI scans are conducted to examine changes in brain activity associated with treatment response and depressive symptomatology, particularly focusing on alterations in neural circuitry and thought processes. Additionally, participants are encouraged to report any changes in medication regimen or other treatments received during the study period.
Eligibility 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)
Contact & Investigator
Martin Walter, Prof. Dr.
PRINCIPAL INVESTIGATOR
Universitätsklinikum Jena - Klinik für Psychiatrie und Psychotherapie
Frequently Asked Questions
Who can join the NCT06410599 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 64 Years, studying Major Depressive Disorder. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06410599 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT06410599 currently recruiting?
Yes, NCT06410599 is actively recruiting participants. Contact the research team at martin.walter@med.uni-jena.de for enrollment information.
Where is the NCT06410599 trial being conducted?
This trial is being conducted at Tübingen, Germany, Jena, Germany.
Who is sponsoring the NCT06410599 clinical trial?
NCT06410599 is sponsored by University Hospital Tuebingen. The principal investigator is Martin Walter, Prof. Dr. at Universitätsklinikum Jena - Klinik für Psychiatrie und Psychotherapie. The trial plans to enroll 60 participants.