Males and females between 18-64 years with a diagnosis of chronic depression MedDRA version: 21.1 Level: LLT Classification code 10066555 Term: Chronic depression System Organ Class: 100000004873
Conditions
Interventions
Trade Name: Ketamin Inresa 2 ml
Product Name: Ketamin Inresa 2 ml
Product Code: 26671.00.00
Pharmaceutical Form: Infusion
Trade Name: Fresenius Kabi Deutschland GmbH Isotone E NaCL 0.9
Product Name:
Sponsors
University Hospital Tuebingen
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Age 18-64 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 & 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 25 sessions of psychotherapeutic treatment (psychoanalysis, depth psychology-based psychotherapy or cognitive behaviour therapy) • Ability to give approval; Ability to understand and voluntarily sign the informed consent form • Ability to adhere to the study visit schedule and other protocol requirements • Contraception: 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 reliable forms of contraception simultaneously or practice complete abstinence from heterosexual contact from study start until 28 days after the last infusion. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 60 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: • Acute substance misuse as primary diagnosis • Neurologic disorders: Stroke, cerebral ischemia, tumor, cerebral infection, autoimmune disease • Disorders with increase of intracranial pressure, e.g. due to head injury • Circulatory disturbance in the brain • 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 • 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 • Pretreatment with ketamine hydrochloride and/ or CBASP • Not or insufficiently treated hypertonia (arterial hypertonia – systolic/ diastolic blood pressure higher than 150/ 100 mmHg at rest) • Not or insufficiently treated hyperthyrodism • Heartache due to insufficient blood circulation (unstable angina pectoris) or heart muscle infarct (myocard infarct) during the last six months • Increased intraocular pressure (glaucoma) and perforating eye injury • Interventions in the area of the upper respiratory passages
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Reduction of depressive symptoms (assessed with Montgomery–Åsberg Depression Rating Scale (MADRS), Schmidtke et al., 1988) between start of and six weeks after end of combination treatment (? t1-t3) in group 1 (ketamine plus CBASP) vs. group 2 (placebo plus CBASP) and in group 1 vs. group 3 (ketamine plus TAU);Secondary Objective: • Depressive Symptoms (assessed with Montgomery– Åsberg Depression Rating Scale (MADRS), Schmidtke et al., 1988) between start of combination treatment and three months after the end of study treatment (? t1- follow up) • Reduction of self-reported depressive symptoms (assessed with Beck-Depression-Inventory (BDI), Beck et al., 2001) between start of and six weeks after end of combination treatment (? t1-t3) in group 1 (ketamine plus CBASP) vs. group 2 (placebo plus CBASP) and in group 1 vs. group 3 (ketamine plus treatment as usual);Primary end point(s): The primary objective of the investigation is to test, whether the combination of ketamine hydrochloride (Ketamin Inresa 2 ml) and CBASP leads to a greater reduction in depressive symptoms between start of and six weeks after end of combination treatment (? t1-t3) in group 1 (ketamine plus CBASP) vs. group 2 (placebo plus CBASP) and in group 1 vs. group 3 (ketamine plus TAU). 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. The MADRS will bei conducted by a rater independent of the the treatment team and blind to treatment condition.;Timepoint(s) of evaluation of this end point: For further detailled information, please refer to p.25 Chapter 3; Figure 1 Week 7 to Week 12 (MADRS), t2 and t3 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Secondary outcome 1 tests if the effects last over a period of three months after the end of treatment. Secondary outcome 2 compares the reduction of self-reported depressive symptoms (assessed with Beck-Depression-Inventory (BDI), Beck et al., 2001) between start of and six weeks after end of combination treatment (? t1-t3) in group 1 (ketamine plus CBASP) vs. group 2 (placebo plus CBASP) and in group 1 vs. group 3 (ketamine plus TAU).;Timepoint(s) of evaluation of this end point: For further detailled information, please refer to p.25 Chapter 3; Figure 1 | — |
Countries
Germany
Contacts
Public ContactPsychiatry and Psychotherapy
University Hospital Tuebingen
Outcome results
None listed