Pharmacologic treatment augmentation in chronic depression “randomized, controlled, double blinded, phase II study”

INTERVENTION: Product Name: Isotonische Kochsalzlösung Fresenius, Infusionslösung,Product Code: PRD2128227,Pharmaceutical Form: SOLUTION FOR INFUSION,Other descriptive name: ,Strength: Sodium Chloride 9g / 1000mL,Pharmaceutical form of the placebo: SOLUTION FOR INFUSION,Route of administration of the placebo: INTRAVENOUS INFUSION,Product Name: Ketamin Inresa 2 ml 50 mg/ml Injektionslösung Ketaminhydrochlorid,Product Code: PRD7673130,Pharmaceutical Form: SOLUTON FOR INJECTION,Other descriptive name: ,Strength: Ketamine Hydrochloride 57.7mg CONDITION: Diagnosis of chronic depression ; MedDRA version: 21.1Level: LLTClassification code: 10066555Term: Chronic depressionSystem Organ Class: 10037175 MedDRA version: 21.1Level: LLTClassification code: 10066555Term: Chronic depressionSystem Organ Class: 10037175 Therapeutic area: Psychiatry and Psychology [F] ‐ Mental Disorders [F03] PRIMARY OUTCOME: 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) Primary end point(s):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. Secondary Objective: INCLUSION CRITERIA: Age 18‐64 at the time of study inclusion Diagnosis of chronic depression: recurrent depressivedisorder, severe or moderate episodes (no full remissionbetween the episodes according to DSM‐IV‐TR (Falkai etal., 2015) [no distinct depressive symptoms for at least twomonths]) or acute depressive episode lasting two or moreyears? Treatment resistance stage 2 according to Thase & Rush(1997): Patient’s symptoms fulfil the criteria of chronicdepression listed above even after at least two appropriatetreatment attempts with two antidepressant medicamentsfrom two different effect categories? Patient’s symptoms fulfil the criteria of chronic depressionlisted above even after executing at least 12 sessions ofpsychotherapeutic treatment (psychoanalysis, depthpsychology‐based psychotherapy or cognitive behaviourtherapy)? Ability to give approval; Ability to understand and voluntarilysign the informed consent form? Ability to adhere to the study visit schedule and otherprotocol re