Ketamine hydrochloride for Chronic depression

Inclusion criteria

• {"criterion_text":"- •\tAge 18-7064 at the time of study inclusion"}
• {"criterion_text":"- •\tDiagnosis 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"}
• {"criterion_text":"- •\tTreatment resistance stage 2 according to Thase & 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"}
• {"criterion_text":"- •\tPatient’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)"}
• {"criterion_text":"- •\tAbility to give approval; Ability to understand and voluntarily sign the informed consent form"}
• {"criterion_text":"- •\tAbility to adhere to the study visit schedule and other protocol requirements"}
• {"criterion_text":"- •\tAll subjects must agree to refrain from donating blood from the first infusion until 28 days after last infusion."}
• {"criterion_text":"- •\tAll subjects must agree not to share medication."}
• {"criterion_text":"- •\tContraception:Male must agree to use a condom during any heterosexual contact with Females of Childbearing Potential (FCBP) from the first infusion until 65 days after the last infusion, even if he has undergone a successful vasectomy, as well as to not donate semen or sperm during this time period.FCBP must agree to use two one reliable forms of contraception simultaneously or practice complete abstinence from heterosexual contact from study start until 28 days after the last infusion.Definition of Females of Childbearing Potential (FCBP)A FCBP is a female who: 1) has achieved menarche at some point, 2) has not undergone a hysterectomy or bilateral oophorectomy or 3) has not been naturally postmenopausal (amenorrhea following cancer therapy does not rule out childbearing potential) for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months)."}

Exclusion criteria

• {"criterion_text":"- •\tCurrent or previous diagnosis of acute substance misuse disorder, except abstinence of at least 3 months. Low dose dependencies of benzodiazepines can be accepted by decision of the study physician."}
• {"criterion_text":"- •\tNeurologic disorders: Stroke, cerebral ischemia, tumor, cerebral infection, autoimmune disease"}
• {"criterion_text":"- •\tDisorders with increase of intracranial pressure, e.g. due to head injury"}
• {"criterion_text":"- •\tCirculatory disturbance in the brain"}
• {"criterion_text":"- •\tPregnant or lactating females"}
• {"criterion_text":"- •\tParticipation in any clinical study or having taken any investigational therapy, which would interfere with the study’s primary end point"}
• {"criterion_text":"- •\tEpilepsy"}
• {"criterion_text":"- •\tHistory 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"}
• {"criterion_text":"- •\tPretreatment with ketamine hydrochloride (Ketamin Inresa 2 ml) and/ or CBASP"}
• {"criterion_text":"- •\tInability to tolerate CBASP (e.g., organic brain disorders, severe cognitive deficits)"}
• {"criterion_text":"- •\tNot or insufficiently treated hypertonia (arterial hypertonia – systolic/ diastolic blood pressure higher than 150/ 100 mmHg at rest)"}
• {"criterion_text":"- •\tNot or insufficiently treated hyperthyrodism"}
• {"criterion_text":"- •\tHeartache due to insufficient blood circulation (unstable angina pectoris) or heart muscle infarct (myocard infarct) during the last six months"}
• {"criterion_text":"- •\tIncreased intraocular pressure (glaucoma) and perforating eye injury"}
• {"criterion_text":"- •\tInterventions in the area of the upper respiratory passages that currently prevent or impede intubation ability"}

Primary endpoints

• {"endpoint_text":"- Depressive symptoms will be assessed by the Montgomery Asberg Depression Rating Scale(MADRS, Schmidtke et al., 1988), a standardized and widely used clinician rating scale. TheMADRS will be conducted by a rater independent of the the treatment team and blind totreatment condition.","definition_or_measurement_approach":"Assessed by the Montgomery Asberg Depression Rating Scale (MADRS); conducted by a rater independent of the treatment team and blinded to treatment condition."}

Germany

Earliest CTIS Part Ii Submission Date

04-04-2024

Latest Decision Or Authorization Date

13-03-2026

Processing Time Days

708

Number Of Sites

2

Number Of Participants

60

Primary sponsor

Full Name

Universitaetsklinikum Tuebingen AöR

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Germany

Contract research organisations

Name

Universitaetsklinikum Tuebingen AöR

Responsibilities

Listed as functional contact with role 'CRO' (public and scientific contact; functionalEmailAddress: manola.zago@med.uni-tuebingen.de)