Pharmacologic treatment augmentation in chronic depressionrandomized, controlled, double blinded, phase II study”

Recruitment & Eligibility

Status: Recruiting

Sex: All

Target Recruitment: 60

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 requirements? Contraception:

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 tohead injury? Circulatory disturbance in the brain? Pregnant or lactating females? Participation in any clinical study or having taken anyinvestigational therapy, which would interfere with thestudy’s primary end point? Epilepsy? History of hypersensitivity to an investigational medicinalproduct or to any drug with similar chemical structure or toany excipient present in the pharmaceutical form of theinvestigational medicinal product? Pretreatment with ketamine hydrochloride (Ketamin Inresa2 ml) and/ or CBASP? Not or insufficiently treated hypertonia (arterial hypertonia –systolic/ diastolic blood pressure higher than 150/ 100mmHg at rest)? Not or insufficiently treated hyperthyrodism? Heartache due to insufficient blood circulation (unstableangina pectoris) or heart muscle infarct (myocard infarct)during the last six months? Increased intraocular pressure (glaucoma) and perforatingeye injury? Interventions in the area of the upper respiratory passages