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

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Universitaetsklinikum Tuebingen AöR

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Psychiatry and Psychology [F] - Mental Disorders [F03]

Trial duration

7 Jul 2023 → ongoing

Decision date (initial)

2024-04-10

Transition trial

Yes

Low-intervention

No

Rare-disease indication

No

Vulnerable population

Yes

External identifiers

EU CT number

2024-512478-86-00

EudraCT number

2019-001692-37

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Therapy

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 (Δ t1-t3) in
group 1 (ketamine plus CBASP) vs. group 2 (placebo
plus CBASP) and in group 1 vs. group 3 (ketamine plus
TAU)

Conditions and MedDRA coding

Diagnosis of chronic depression

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 1

1. • Age 18-7064 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 12 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• All subjects must agree to refrain from donating blood from the first infusion until 28 days after last infusion.• All subjects must agree not to share medication.• 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 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 1

1. • Current 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.• 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 (Ketamin Inresa 2 ml) and/ or CBASP• Inability to tolerate CBASP (e.g., organic brain disorders, severe cognitive deficits)• 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 that currently prevent or impede intubation ability

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. 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.

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Placebo 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Universitaetsklinikum Tuebingen AöR

Sponsor organisation

Universitaetsklinikum Tuebingen AöR

Address

Geissweg 3, Innenstadt Innenstadt

City

Tuebingen

Postcode

72076

Country

Germany

Scientific contact point

Organisation

Universitaetsklinikum Tuebingen AöR

Contact name

CRO

Public contact point

Organisation

Universitaetsklinikum Tuebingen AöR

Contact name

CRO

Locations

1 EU/EEA country · 4 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 11 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

4 submissions — initial application plus substantial / non-substantial modifications