A study to measure how well seltorexant works in adult depressed patients and how safe it is both for short- and long-term use when taken with another antidepressant

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

18 Mar 2025 → ongoing

Decision date (initial)

2025-03-07

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

Yes

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Efficacy, Safety, Therapy

Part 1 (efficacy)
To assess the efficacy of seltorexant 20 mg compared with placebo as
adjunctive therapy to an SSRI/SNRI antidepressant in improving depressive symptoms in participants with MDDIS who have had an inadequate response to current SSRI/SNRI antidepressant therapy
Part 2 (efficacy)
To assess the efficacy of seltorexant 20 mg compared with placebo as
adjunctive therapy to an SSRI/SNRI antidepressant in delaying relapse of
depressive symptoms in participants with MDDIS who have had an
inadequate response to current SSRI/SNRI antidepressant therapy
and who have a stable response following OL seltorexant treatment

Conditions and MedDRA coding

Major Depressive Disorder with Insomnia Symptoms

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. Participants in Part 1 and Direct Enrollers to Part 2: Participants aged 18 to 74 years (inclusive).
2. Participants must be medically stable based on the following performed at screening: physical examination, vital signs, and 12-lead ECG performed at screening and baseline
3. Meet DSM-5 diagnostic criteria for MDD, without psychotic features.
4. Have had an inadequate response to at least 1 but no more than 2 antidepressants, administered at an adequate dose and duration started in the current episode of depression. An adequate trial is defined as an antidepressant treatment for at least 6 weeks on a stable dose at or above the minimum therapeutic dose specified in the MGH-ATRQ
5. Is receiving and tolerating well any one of the following SSRI or SNRI for depressive symptoms at screening, in any formulation and approved in the participating country: citalopram, duloxetine, escitalopram, fluvoxamine, fluoxetine, milnacipran, levomilnacipran, paroxetine, sertraline, venlafaxine, desvenlafaxine, vilazodone, or vortioxetine at a stable dose (at therapeutic dose level) for at least 6 weeks
6. Having a major depressive episode of at least moderate severity, as assessed with SIGH-D in a blinded manner at screening and must not demonstrate a clinically significant improvement from the beginning to end of screening
7. Body mass index (BMI) between 18 and 40 kg/m2.
8. Participants Entering After Completing Part 1 (ie, Rollover Participants) must meet the following criteria: Must have completed Part 1 DB treatment phase
9. Can consistently tolerate study drug

Exclusion criteria 6

1. Participants in Part 1 and Part 2 Direct Enrollers: Has a current or recent history of homicidal ideation or clinically significant suicidal ideation within the past 3 months, or a history of suicidal behavior within the past 6 months.
2. Has a history of treatment-resistant MDD, defined as a lack of response to 2 or more adequate antidepressant treatments in the current episode
3. Current active DSM-5 diagnosis of obsessive-compulsive disorder, posttraumatic stress disorder, anorexia nervosa, bulimia nervosa or fibromyalgia. All of these disorders need to be in remission for at least 1 year for the participant to be enrolled.
4. Has history or current diagnosis of a psychotic disorder, bipolar disorder, intellectual disability, autism spectrum disorder, borderline personality disorder, or somatoform disorders.
5. Has any significant sleep disorder, including but not limited to untreated/uncontrolled obstructive sleep apnea, restless leg syndrome, or parasomnias. Participants with insomnia disorder or well controlled obstructive sleep apnea are allowed
6. Has a history of moderate to severe substance use disorder including alcohol use disorder according to DSM-5 criteria within 6 months before screening.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 2

1. Part 1 (Efficacy): Change from baseline to Day 43 in the MADRS total score.
2. Part 2 Time from randomization to the first relapse during the double-blind (DB) Maintenance Phase in participants who achieve a stable response at the end of open-label (OL) seltorexant treatment

Investigational products

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

Test 1

Placebo 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 6

Locations

9 EU/EEA countries · 67 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 146 files

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

Application history

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