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New treatment option for Major Depressive Disorder
Official title Pharmacologic Treatment Augmentation in Chronic Depression
ClinicalTrials.gov ID: NCT06410599
What this study is testing
What is Ketamine?
Ketamine is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for major depressive disorder.
Also referred to as Ketamine hydrochloride (Ketamin Inresa 2 ml).
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 64
You may be able to join if
- 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...
- Treatment resistance stage 2 according to (Thase and Rush, 1997): Patient's symptoms fulfil the criteria of chronic depression listed above even...
- Patient's symptoms fulfil the criteria of chronic depression listed above even after executing at least 12 sessions of psychotherapeutic treatment...
- Understand and voluntarily sign an informed consent document prior to any study related assessments/ procedures.
You likely can't join if
- 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
See the full eligibility 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...
- 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...
- 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...
- 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...
- 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...
- All people must agree to refrain from donating blood from the first infusion until 28 days after last infusion.
- All people must agree not to share medication.
- 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...
- 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...
- 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)
The study team makes the final eligibility decision.
Where it's taking place
- Tübingen, Baden-Würtemberg, Germany
- Jena, Thuringia, Germany
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 64 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Tübingen, Baden-Würtemberg, Germany; Jena, Thuringia, Germany. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.