Efficacy, safety, tolerability, and pharmacokinetics of MIJ821 inpatients with treatment-resistant depressio
- Conditions
- Treatment Resistant DepressionMedDRA version: 20.0Level: PTClassification code 10057840Term: Major depressionSystem Organ Class: 10037175 - Psychiatric disordersTherapeutic area: Psychiatry and Psychology [F] - Psychological processes [F02]
- Registration Number
- EUCTR2018-003002-12-ES
- Lead Sponsor
- ovartis Farmacéutica, S.A.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 70
- Signed informed consent.
- Male and female subjects, 18 to 65 years of age
(inclusive) at screening.
- DSM-5 defined major depressive episode at the time
of screening
- Montgomery-Åsberg Depression Rating Scale
(MADRS) score = 24 at baseline
- Failure to respond to two or more antidepressant
treatments, at least one of which is in the current
depressive episode, with adequate dose and duration.
- Stable dose of psychotropic drugs at screening
defined as no changes in dose or type of
antidepressants, antipsychotics, or mood stabilizers
for at least 2 weeks prior to randomization if applicable.
- No new antidepressant initiated 4 weeks or less
before baseline, and 6 weeks or less before baseline if
subject is initiated on fluoxetine
- At least one prior clinical depressive episode
(recurrent major depressive disorder).
- Able to communicate well, and to understand and
comply with study requirements
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 66
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
- Any prior or current diagnosis of bipolar disorder,
schizophrenia, or schizoaffective disorder at screening.
- Current alcohol or substance use (other than nicotine
or caffeine) meeting DSM-5 criteria for addiction,
within the past month.
- Prior suicidality caused by or associated with
ketamine, as identified by prior psychiatric history
assessed by the investigator, and augmented by
medical records and third party report (family, friends,
clinician-treaters) where available.
- Acute serious and/or imminent suicidal ideation
and/or intent within the prior 2 weeks, or any suicide
attempt within the prior 4 weeks at screening.
- Use of other investigational drugs at the time of
randomization, or within 30 days or 5 half-lives of
randomization, whichever was longer; or longer if
required by local regulations at baseline.
- Current pregnancy or lactation.
- Positive HIV, Hepatitis B or C test.
- Resting QTcF =450 msec (male) or =460 msec
(female) at pre-treatment baseline
- History of multiple and recurring allergies or allergy to
the investigational compound/compound class being
used in this study.
- History of malignancy of any organ system (other
than localized basal cell carcinoma of the skin or insitu
cervical cancer), treated or untreated, within the
past 3 years, regardless of whether there is evidence
of local recurrence or metastases.
- Women of child-bearing potential, defined as all
women physiologically capable of becoming pregnant,
unless they are using highly effective methods of
contraception during dosing and for 1 week after
stopping of investigational drug.
- History of hypersensitivity to any of the study
treatments or excipients or to drugs similar to chemical
classes.
- Current diagnosis of borderline personality disorder
or antisocial personality disorder, based on DSM-5
criteria.
- Current acute depressive episode lasting longer than
two years continuously, defined as no two week or
longer period where depressive symptoms are
subsyndromal in severity for a full DSM-5 acute major
depressive episode.
- Considered by the investigator, for any other reason,
to be an unsuitable candidate for the study.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method