Trial results for a study investigating Major Depressive Disorder were posted on ClinicalTrials.gov on 2026-01-26, showing a mean change of 7.1 points in the Montgomery-Asberg Depression Rating Scale (MADRS) score with an ANOVA p-value of 0.05 among 9 participants.
Background
Major Depressive Disorder (MDD) is a significant mental health condition characterized by persistent sadness and loss of interest, impacting daily life. Despite ongoing efforts to address mental health challenges, particularly in vulnerable populations such as Veterans at high risk for suicide, there remains a need for targeted interventions. This study aimed to explore the feasibility and acceptability of a novel adjunctive cognitive remediation (CR) therapy, designed to improve problem-solving strategies for real-world stressors, including those that may trigger suicidal thoughts.
Trial design
This completed study, designated as Phase NA, enrolled 9 participants diagnosed with Major Depressive Disorder. The trial investigated a novel adjunctive cognitive remediation (CR) therapy, including manualized "Bridging" sessions, delivered via telehealth. The study was designed as an acceptability/feasibility study with a single active treatment arm. The key measurement reported was the change in Montgomery-Asberg Depression Rating Scale (MADRS) score from pre- to post-treatment.
Key results
The trial reported key measurements related to the change in depression severity:
- For the outcome "Change in Montgomery-Asberg Depression Rating Scale (MADRS) Score: Pre- Minus Post-treatment Intervention", observed in the active treatment arm:
- A mean change of 7.1 (Standard Deviation 1.6) was reported. This was measured as a score on a scale.
A key analysis using ANOVA reported a p-value of 0.05.
What this means
The results of this feasibility and acceptability study indicate a potential signal for the novel cognitive remediation intervention in patients with Major Depressive Disorder. A mean change of 7.1 points on the MADRS scale, coupled with an ANOVA p-value of 0.05, suggests a statistically notable effect in this small cohort. However, given the enrollment of only 9 participants, these findings are preliminary and require validation through larger, controlled clinical trials to confirm efficacy and generalizability for patients with depression, particularly Veterans at high risk for suicide.
Source
The information regarding these trial results was obtained from ClinicalTrials.gov, a public database of clinical studies. The results for the study NCT04952532, titled "A Novel Cognitive Remediation Intervention Targeting Poor Decision-making and Depression in Veterans at High Risk for Suicide: A Safe, Telehealth Approach During the COVID-19 Pandemic", were posted on 2026-01-26 on clinicaltrials.gov.