A study to evaluate if aticaprant added to a current antidepressant and given up to one year is safe and would help improve depression.

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Janssen Cilag International

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

12 Jun 2023 → 8 May 2025

Decision date (initial)

2024-10-03

Transition trial

Yes

Low-intervention

No

Rare-disease indication

No

Vulnerable population

Yes

External identifiers

EU CT number

2023-508163-74-00

EudraCT number

2022-000430-42

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Safety, Efficacy, Therapy

To assess the long-term safety and tolerability of aticaprant administered as adjunctive therapy to a current antidepressant (SSRI or SNRI) in all participants with MDD

Conditions and MedDRA coding

Major Depressive Disorder

Regulatory references

Scientific advice from competent authorities

European Medicines Agency

Plan to share IPD

Yes

IPD plan description

The data sharing policy of the Janssen Pharmaceutical Companies of Johnson & Johnson is available at www.janssen.com/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 9

1. Transferred patients: - Participants must have completed the Double Blind Treatment Phase of Study 67953964MDD3001 or Study 67953964MDD3002 study.
2. Participant must be medically stable on the basis of physical examination, medical history, vital signs (including blood pressure), and 12-lead ECG performed at baseline and prior to Open Label treatment initiation.
3. Direct entry patients: - Male or female, aged 18 to 74 years of age, inclusive.
4. Be medically stable on the basis of physical examination, medical history, vital signs, and 12-lead ECG performed at screening and baseline
5. Be medically stable on the basis of clinical laboratory tests performed at screening
6. Meet DSM-5 diagnostic criteria for recurrent or single episode MDD, without psychotic features. Participants 65 years of age or older must have had the first onset of depression prior to 55 years of age.
7. Have had an inadequate response to at least 1 oral antidepressant treatment, administered at an adequate dose and duration in the current episode of depression.
8. Is receiving and tolerating well a SSRI/SNRI for depressive symptoms at screening, at a stable dose for at least 6 weeks
9. Have a HDRS-17 total score of 20 or higher at the first and second screening interviews and must not demonstrate a clinically significant improvement between the first and the second independent HDRS-17 assessments

Exclusion criteria 10

1. Transferred-entry participants: - Participant has been non-compliant with the study intervention administration in the Double Blind (DB) Treatment Phase in either of Studies 67953964MDD3001 or 67953964MDD3002
2. The evaluation of the benefit versus risk of continued aticaprant treatment is not favorable for the participant in the opinion of the investigator.
3. Participant is reporting suicidal ideation with intent to act or suicidal behavior at baseline.
4. Participant has taken any prohibited therapies that would not permit dosing on Day 1, as noted in the pre-study and concomitant therapy section.
5. Participant has any condition or situation/circumstance for which, in the opinion of the investigator, participation would not be in the best interest of the participant (eg, compromise the well-being) or that could prevent, limit, or confound the protocol-specified assessments.
6. Direct-entry participants: - Have had in the current depressive episode, no response (treatment failure) to 5 or more antidepressant treatments including the current SSRI/SNRI
7. Has a history or evidence of clinically meaningful noncompliance with current antidepressant therapy.
8. Has a history of moderate-to-severe substance use disorder including alcohol use disorder according to DSM-5 criteria within 6 months before screening.
9. Has had in the current episode an inadequate response to adequate course of intravenous or intranasal ketamine or esketamine, electroconvulsive therapy (i.e, at least 7 treatments), vagal nerve stimulation, or a deep brain stimulation device
10. Has a current homicidal ideation/intent, per the investigator's clinical judgment, or has suicidal ideation with some intent to act within 3 months prior to the start of the screening phase

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 8

1. AEs including AEs of special interest (AESI)
2. Change from baseline in vital signs
3. Weight/body mass index (BMI)
4. Suicidality assessment using the Columbia Suicidality Severity Rating Scale (C-SSRS)
5. Laboratory parameters
6. 12-lead ECG
7. Assessment of withdrawal symptoms using the Physician Withdrawal Checklist, 20-item (PWC-20).
8. Proportion of participants with clinically relevant sexual dysfunction over time in the Arizona Sexual Experiences Scale (ASEX) score.

Investigational products

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

Test 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Janssen Cilag International

Sponsor organisation

Janssen Cilag International

Address

Turnhoutseweg 30

City

Beerse

Postcode

2340

Country

Belgium

Scientific contact point

Organisation

Janssen Cilag International

Contact name

CTIS Point of Contact

Public contact point

Organisation

Janssen Cilag International

Contact name

CTIS Point of Contact

Third parties 8

Locations

11 EU/EEA countries · 79 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

Summary of results Art. 37(4) CTR

Layperson summary Annex V

Documents 145 files

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

Application history

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