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Table 2 Summary of key randomized controlled trials evaluating the effects of aspirin use on mental illness and symptoms.

From: Aspirin: a review of its neurobiological properties and therapeutic potential for mental illness

Author, year; study Study design Agent/dosage Sample Psych measure Presentation of results Key finding
Non-clinical population
Dinnerstein, 1970 DB-RCT ASA 600 mg + placebo 'energizer'/'tranquilizer' versus lactose 600 mg + placebo 'energizer'/'tranquilizer' 80 healthy male college students CMS   ASA had no direct and fixed effect on mood, but acts to modulate the effect of placebo or other contextual variables
Lieberman, 1987 DB-RCT 2* to 6*sessions: caffeine 64 mg, or ASA 800 mg, or caffeine 64 mg + ASA 800 mg, or caffeine 128 mg + ASA 800 mg, or placebo in Latin-square design 20 healthy men 18 to 35 years old, caffeine intake <400 mg/day, non-smokers 6 sessions PMS, visual analog mood scales, NVMS, SSS, and performance tests Mean and SEM Caffeine alone and caffeine +ASA improved vigilance, self-reported efficiency and mood compared with ASA alone and placebo
Kang, 2007; Women's Health Study Cohort study within a DB-RCT ASA 100 mg or placebo on alternate days 6,377 women >65 years old TICS-M, immediate and delayed recalls of the EBMT and delayed recall of the TICS-M, 10-word list and category fluency (naming as many animals as possible in 1 minute) Mean and SD ASA users did not differ in overall performance in any of the cognitive assessments, from the 1* assessment (after 5.6 years) to the 3* (after a mean 9.6 years), or in their average cognitive decline during 3 to 6 years of follow-up. ASA users performed better in category fluency, particularly in the final assessment
Kudielka, 2007 DB-RCT ASA 100 mg, or propranolol 80 mg, or ASA 100 mg + propranolol 80 mg, or placebo 73 healthy subjects TSST. Cortisol from six saliva samples taken before and after the stress exposure Mean and SD 5 days: groups did not differ in their cortisol responses
Clinical population
Clarke, 2003; VITAL trial collaborative group; dementia or MCI DB-RC; 4-week placebo-controlled run-in period before randomization + 12-week treatment ASA 81 mg, or placebo AND folic acid 2 mg + vitamin B12 1 mg, or placebo AND vitamin E 500 mg + vitamin C 200 mg, or placebo in 2 × 2 × 2 factorial design 149 NII, 12 to 26 patients MMSE score or <27 patients TICS-M score, naïve to study medications. Follow-up: 137 for biochemical outcomes, 128 for cognitive outcomes TICS-M, MMSE, ADAS Median percentage reduction 12 weeks of ASA was effective in reducing biochemical factors (thromboxane) associated with cognitive impairment in people at risk of dementia. No effect of treatment on cognitive function
AD2000, 2008; Alzheimer's disease OL-RCT ASA 75 mg yes/no 310 NII MMSE, behavioral symptoms Mean and SD At 3 -year follow-up: no differences in scores, significantly higher risk of bleeding
Price, 2008; asymptomatic atherosclerosis DB-RCT ASA 100 mg or placebo 3350 participants 50-75 years old Summary cognitive score = tests of memory, executive function, non-verbal reasoning, mental flexibility, and information processing Mean and SD At 5-year follow-up: no differences
Gałecki, 2009; first depressive episode OL-RCT fluoxetine 20 mg, or fluoxetine 20 mg + ASA 150 mg 77 participants HDRS   No differences in HDRS between fluoxetine group and fluoxetine + ASA group
Laan, 2010; schizophrenic spectrum disorders DB-RCT ASA 1000 mg/day or placebo adjuvant to antipsychotic + pantoprazole 40 mg/day 70 adults
PANSS ≥60, 2 items ≥4, illness duration <10 years. 2-week placebo run-in period, and only those who achieved over 80% compliance were randomized
PANSS Mean and SD Adjuvant ASA reduced overall psychopathology and positive symptoms at 3 months. No significant results in other subscales. ASA had greater effect on overall psychopathology in individuals with more altered immune function. ASA significantly reduced overall psychopathology in individuals with the lowest Th1:Th2 ratios
  1. ADAS, Alzheimer's Disease Assessment Scale; ASA, acetylsalicylic acid (aspirin); DB, double-blind; EBMT, East Boston Memory Test; HDRS, Hamilton Depression Rating Scale; MCI, mild cognitive impairment; MMSE, Mini-Mental State Examination; NII, Non-institutionalized individuals; NVMS, Nestle Visual Analog Mood Scale; OL, open-label; PANSS, Positive and Negative Syndrome Scale; PMS, Profile of Mood States RCT, randomized controlled trial; SD, standard deviation; SEM, standard error of the mean; SSS, Stanford Sleepiness Scale; Th, T-helper; TICS-M, Telephone Interview for Cognitive Status - Modified; TSST, Trier Social Stress Test.