A Home-based Study Using Mobile Technology to Test Whether BI 1358894 is Effective in People With Depression

Boehringer Ingelheim

Status and phase: Terminated; Phase 2

Conditions: Depressive Disorder, Major

Treatments: Drug: Placebo; Drug: BI 1358894

Study type: Interventional

Funder types: Industry

Identifiers

NCT04423757

1402-0014

Details and patient eligibility

About

This is a home-based study in adults with depression. People who have been diagnosed with Major Depressive Disorder can participate in the study. Participants can take part if they are being treated for their depression but still have symptoms. The purpose of this study is to find out whether a medicine called BI 1358894 helps people with depression.

Participants are in the study for about 2 months and do not need to visit a study site during this time. All study visits are conducted at participant's home by a mobile study nurse, by videoconference, and by phone calls. Participants are put into 2 groups by chance. One group takes BI 1358894 tablets. The other group takes placebo tablets. Placebo tablets look like BI 1358894 tablets but do not contain any medicine.

The participants answer questions about the symptoms of their depression. We then compare the results between the BI 1358894 and placebo groups. The doctors and nurses also regularly check the general health of the participants.

Enrollment: 45 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Established diagnosis of Major Depressive Disorder, single episode or recurrent, as confirmed at the time of screening by the Structured Clinical Interview for Diagnostic and Statistical Manual of Mental Disorders v5 (DSM-5, SCID-5), with a duration of current depressive episode ≥ 8 weeks and ≤ 12 months at the time of screening visit.
• Montgomery-Åsberg Depression Rating Scale (MADRS) total score ≥ 22 at screening, as confirmed by a trained rater. In addition, trial participants must have a score of ≥ 3 on the Reported Sadness item on MADRS.
• A documented ongoing monotherapy treatment of ≥ 8 weeks at the screening visit, with a protocol specified SSRI or SNRI (refer to the ISF) at adequate dose (at least minimum effective dose as per prescribing information and as confirmed per detectable drug levels in the screening blood or urine sampling).
• Male and female participants, 18 to 65 years of age, both inclusively at the time of consent.
• Women of child-bearing potential (WOCBP)2 able and willing to use two methods of contraception, which include one highly effective method of birth control per ICH M3 (R2) that results in a low failure rate of less than 1%, plus one barrier method.
• Signed and dated written informed consent in accordance with ICH-GCP and local legislation prior to admission to the trial.
• Able to communicate well, and to understand and comply with trial requirements.

Exclusion criteria

• Per DSM-5, had ever met diagnostic criteria for schizophrenia, schizoaffective disorder, schizophreniform disorder, bipolar disorder, delusional disorder or MDD with psychotic features as assessed by the Structured Clinical Interview for DSM -5 (SCID-5) at the time of screening.
• Diagnosis of any other mental disorder (in addition to those as described in Exclusion Criterion #1) that was the primary focus of treatment within 6 months prior to screening or at baseline (as per clinical discretion of the investigator).
• Diagnosis with antisocial, paranoid, schizoid or schizotypal personality disorder as per DSM-5 criteria, at the time of screening visit. Any other personality disorder at screening visit that significantly affects current psychiatric status and likely to impact trial participation, as per the judgement of investigator.
• Diagnosis of a substance related disorder within 3 months prior to screening visit (with exception of caffeine and tobacco).
• History of seizure disorders, stroke, brain tumor or any other major neurological illness that can impact participation in the trial.
• History of 4 or more unsuccessful monotherapy treatments (at adequate dosage and duration, per local prescribing information of the product) with an approved antidepressant medication for the current ongoing major depressive episode. These include ongoing monotherapy treatment with a protocol specified SSRI or SNRI as described in Inclusion Criterion #3.
• Any suicidal behavior in the past 12 months prior to screening (per investigator judgement including an actual attempt, interrupted attempt, aborted attempt, or preparatory acts or behaviour).
• Any suicidal ideation of type 4 or 5 in the Columbia Suicide Severity Rating Scale (CSSRS) in the past 3 months prior to screening or at screening or baseline visit (i.e. active suicidal thought with method and intent but without specific plan, or active suicidal thought with method, intent and plan).
• Further exclusion criteria apply

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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45 participants in 2 patient groups, including a placebo group

BI 1358894

Experimental group

Description:

125 milligram (mg) BI 1358894 taken orally as three film-coated tablets (1x 25mg and 2x 50mg) once a day in the morning for six weeks.

Treatment:

Drug: BI 1358894

Placebo

Placebo Comparator group

Description:

Placebo matching BI 1358894 taken orally as three film-coated tablets once a day in the morning for six weeks.

Treatment:

Drug: Placebo