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

Phase 1

• Conditions: Males and females between 18-64 years with a diagnosis ofchronic depression; MedDRA version: 21.1Level: LLTClassification code 10066555Term: Chronic depressionSystem Organ Class: 100000004873; Therapeutic area: Psychiatry and Psychology [F] - Mental Disorders [F03]

• Registration Number: EUCTR2019-001692-37-DE
• Lead Sponsor: niversity Hospital Tuebingen

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-07-19
• Last Update Posted: 10 May 2021

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 60

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

• 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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified