NCT05462652

Self-guided Treatment for Adolescents Navigating Depression

Completed NA Results posted Last updated 12 June 2024

What this trial tests

NA trial testing Active Intervention in Depressive Symptoms in 223 participants. Completed in 21 April 2023.

Timeline

28 July 2022

Primary endpoint
21 April 2023

21 April 2023

Quick facts

Lead sponsor	Limbix Health, Inc.
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	treatment
Enrollment	223
Start date	28 July 2022
Primary completion	21 April 2023
Estimated completion	21 April 2023
Sites	1 location across United States

Drugs / interventions tested

• Active Intervention — full drug profile →

Conditions studied

• Depressive Symptoms — all drugs for Depressive Symptoms →
• Depression — all drugs for Depression →
• Depressive Disorder — all drugs for Depressive Disorder →
• Depressive Episode — all drugs for Depressive Episode →

Sponsor

Limbix Health, Inc.

Who can join

Adults 13 to 21, any sex, with Depressive Symptoms or Depression. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Depressive Symptom Severity at Post-intervention Primary · Post-intervention (5 week timepoint)

Measured by the Patient Health Questionnaire (PHQ-8), an 8-item participant-report measure for screening for depression and for establishing depression severity. The total score ranges from 0-24, with a higher score indicating greater depression symptom severity.

Group	Value	95% CI
Active Intervention	8.39	± 0.38
Usual Care	11.03	± 0.37

Intervention Response at Post-intervention Secondary · Change from baseline to post-intervention (5 weeks)

Measured by the Patient Health Questionnaire (PHQ-8) an 8-item participant-report measure for screening for depression and for establishing depression severity. The total score ranges from 0-24, with a higher score indicating greater depression symptom severity. Intervention response is defined as a 50% reduction in PHQ-8 score from baseline.

Intervention Response (Yes)

Group	Value	95% CI
Active Intervention	31.7	22.5 – 40.8
Usual Care	11.6	5.2 – 18.0

Intervention Response (No)

Group	Value	95% CI
Active Intervention	68.3	59.2 – 77.5
Usual Care	88.4	82.0 – 94.8

Remission at Post-intervention Secondary · Post-intervention (5 week timepoint)

Measured by the Patient Health Questionnaire (PHQ-8) an 8-item participant-report measure for screening for depression and for establishing depression severity. The total score ranges from 0-24, with a higher score indicating greater depression symptom severity. Remission is defined as a PHQ-8 score less than 5 at post-intervention.

Group	Value	95% CI
Active Intervention	24.9	16.4 – 33.4
Usual Care	9.4	3.9 – 15.0

Clinically-meaningful Reduction in Severity at Post-intervention Secondary · Change from baseline to post-intervention (5 weeks)

Measured by the Patient Health Questionnaire (PHQ-8) an 8-item participant-report measure for screening for depression and for establishing depression severity. The total score ranges from 0-24, with a higher score indicating greater depression symptom severity. Clinically-meaningful reduction is defined as a ≥5 point reduction in PHQ-8 score from baseline.

Group	Value	95% CI
Active Intervention	40.5	30.9 – 50.1
Usual Care	15.8	8.9 – 22.7

Adverse events — posted to ClinicalTrials.gov

Time frame: Through study completion, up to 11 weeks after randomization. Reporting threshold: 3%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Active Intervention

Serious: 2/111 (2%)

Deaths: 0/111

Usual Care

Serious: 1/112 (1%)

Deaths: 0/112

Serious adverse events (2 terms)

Reaction	System	Active Intervention	Usual Care
Hospitalization	Psychiatric disorders	—	—
Victim of violence	Social circumstances	—	—

Most-reported serious reactions: Hospitalization, Victim of violence.

Data from ClinicalTrials.gov NCT05462652 adverse events section.

Sponsor's own description

The goal of this study is to test whether an investigational mobile app can be a helpful treatment option for adolescents with symptoms of depression. Adolescents aged 13 to 21 with depression symptoms can be part of this study if eligible.

Eligible participants will be randomly assigned to one of two groups: one group will receive the mobile app intervention in addition to their usual care and the other group will simply continue their usual care for symptoms of depression. Both groups will have 5 weeks to use a study app, and will complete assessments during the intervention period, at post-intervention, and at one month follow-up.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Assessing the Efficacy and Safety of a Digital Therapeutic for Symptoms of Depression in Adolescents: Protocol for a Randomized Controlled Trial.
   Furman DJ, Hall SA, Avina C, Kulikov VN, et al · · 2023 · cited 1× · PMID 37971800 · DOI 10.2196/48740