PACt-MD
Trial question
What is the role of cognitive remediation plus transcranial direct current stimulation targeting prefrontal cortex in patients with remitted major depressive disorder and MCI?
Study design
Multi-center
Single blinded
RCT
Population
Characteristics of study participants
62.0% female
38.0% male
N = 375
375 patients (232 female, 143 male).
Inclusion criteria: older adult patients, aged ≥ 60 years, with remitted major depressive disorder and MCI.
Key exclusion criteria: high risk for suicide; significant neurological condition; unstable medical illness; receipt of cognitive enhancer within the past 6 weeks; alcohol or other substances use disorder within the past 12 months; schizophrenia, bipolar disorder, or OCD.
Interventions
N=188 active CR and active tDCS (active cognitive remediation plus active transcranial direct current stimulation 5 days per week for 8 weeks followed by 5 days once every 6 months and daily at-home cognitive remediation).
N=187 sham CR and sham tDCS (sham cognitive remediation plus transcranial direct current stimulation 5 days per week for 8 weeks followed by 5 days once every 6 months and daily at-home sham cognitive remediation).
Primary outcome
Delayed reduction in global cognitive Z score at month 60
0.76 points
0.97 points
1.0 points
0.7 points
0.5 points
0.2 points
0.0 points
Active CR and active
tDCS
Sham CR and sham
tDCS
Significant
decrease ▼
Significant decrease in delayed reduction in global cognitive Z score at month 60 (0.76 points vs. 0.97 points; AD -0.21 points, 95% CI -0.35 to -0.07).
Secondary outcomes
No significant difference in delayed reduction in executive function Z score at month 60 (0.79 points vs. 0.96 points; AD -0.17 points, 95% CI -0.39 to 0.05).
No significant difference in delayed reduction in global cognitive Z score at month 2 (-0.17 points vs. -0.11 points; AD -0.06 points, 95% CI -0.12 to 0.01).
Conclusion
In older adult patients, aged ≥ 60 years, with remitted major depressive disorder and MCI, active CR and active tDCS were superior to sham CR and sham tDCS with respect to delayed reduction in global cognitive Z score at month 60.
Reference
Tarek K Rajji, Christopher R Bowie, Nathan Herrmann et al. Slowing Cognitive Decline in Major Depressive Disorder and Mild Cognitive Impairment: A Randomized Clinical Trial. JAMA Psychiatry. 2025 Jan 1;82(1):12-21.
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