Page 89 - ITPS-8-1

INNOSC Theranostics and
Pharmacological Sciences Brain glutamate level after treatment with NAC

2.5. Intervention and assessments Table 3 shows the safety parameters between the

A competent clinical psychologist diagnosed patients with placebo and NAC arms at baseline and after 10 weeks of
OCD were diagnosed based on the DSM-5 criteria. After Table 1. Demographic characteristics of patients (n=54)
obtaining informed written consent, 60 patients were during enrollment
enrolled. Next, address, phone number, and demographics
were collected using a prepared data sheet. However, three Variables Placebo+SSRI NAC+SSRI P
patients from the placebo arm and three from the NAC (n=27) (n=27)
arm dropped out of the trial. Therefore, 27 and 27 patients (Mean±SD) (Mean±SD)
from the placebo and NAC arms completed the trial. Age in years 29.00±9.18 26.83±5.53 0.10 x
Therefore, the intention-to-treat protocol included 60, and Range (18 – 48) Range (18 – 42)
the per-protocol treatment included 54 patients, who were Sex
available to complete the study. At baseline, the patients Male 12/27 (44.44%) 11/27 (40.74%)
were assessed by Y-BOCS. Subsequently, patients were Female 15/27 (55.55%) 16/27 (59.25%) 0.61 y
given NAC and placebo boxes. The study included three Note: Unpaired t-test; Chi-squared (χ ) test
y
x
2
visits: one baseline visit and two follow-up visits after Abbreviations: NAC, N-acetylcysteine; SD, standard deviation;
4 and 10 weeks with a visit window of ±4 days. Patients SSRI: Selective serotonin reuptake inhibitor.
were visited to assess their response to treatment using the
Y-BOCS after 4 and 10 weeks. Table 2. Comparison of the Y‑BOCS scores between the
control and intervention arms (at baseline and after 4 and
2.6. Statistical analysis 10 weeks of treatment)
All data were presented as a mean ± standard deviation, Variable Placebo+SSRI NAC+SSRI P x
and analysis was performed using Microsoft Excel. For (n=27) (n=27)
quantitative and qualitative variables, an unpaired t-test Mean±SD Mean±SD
and Chi-squared (χ ) test were used, respectively. P < 0.05 At baseline 25.07±2.21 25.51±3.05 0.55
2
was considered significant. After 4 weeks 24.15±3.66 21.96±3.53 0.03
After 10 weeks 23.65±2.20 17.15±5.20 0.00
2.7. Patient assessment tools
Note: Unpaired t-test.
x
DSM-5 and Y-BOCS were used as patient assessment tools. Abbreviations: NAC: N-acetyl cysteine; SSRI: Selective serotonin
reuptake inhibitor; Y-BOCS: Yale–Brown obsessive scale.
3. Results
Table 3. Safety parameters between the placebo and NAC
As shown in Figure 1, 60 patients were enrolled based on arms (at baseline and after 10 weeks of treatment)
the eligibility criteria. Patients were randomized into two
arms to receive SSRIs plus placebo and SSRIs plus NAC. Variables Placebo+SSRI NAC+SSRI P x
(n=27) (n=27)
Table 1 shows the demographic characteristics of the Mean±SD Mean±SD
patients (n = 54) at baseline. No significant difference Serum ALT (U/L)
was found in age and sex between the two arms (P = 0.10 At baseline 27.50±18.17 26.96±14.38 0.90
and 0.61).
After 10 weeks 28.81±18.99 26.18±13.25 0.56
Table 2 shows the Y-BOCS score of the patients at Serum AST (U/L)
baseline and after 4 and 10 weeks. At baseline, the Y-BOCS Atbaseline 26.84±13.74 24.41±8.32 0.44
scores in the placebo (25.07 ± 2.21) and NAC (25.51 ± 3.05)
arms were not significantly different (P = 0.55). Toward the After 10 weeks 28.23±1.98 23.81±6.47 0.15
end of this trial, the Y-BOCS score reduction in the NAC Serum creatinine (mg/dL)
arm was significantly different from that in the placebo At baseline 0.79±0.19 0.79±0.16 0.85
arm (P < 0.05). The Y-BOCS score decreased from 25.51 ± After 10 weeks 0.80±0.17 0.78±0.13 0.48
3.05 to 17.15 ± 5.20 in the NAC arm (Figure 2). The score ECG
in the placebo arm changed from 25.07 ± 2.21 to 23.65 ± Normal 5 12 0.07 z
2.20. By the end of week 4, the first sign of an improving Abnormal 0 1
effect of NAC on the Y-BOCS score was noted (P = 0.03, x z 2
Figure 2). Of 27 patients in the NAC arm, 20 (74.06%) Note: Unpaired t-test; Chi-squared (χ ) test.
Abbreviations: ALT: Alanine transaminase; AST: Aspartate
reported a complete clinical response. In the placebo arm, aminotransferase; ECG: electrocardiogram; NAC: N-acetylcysteine;
this ratio was 7.40% (1/27). SD: Standard deviation; SSRI: Selective serotonin reuptake inhibitor.

Volume 8 Issue 1 (2025) 83 doi: 10.36922/itps.4887