Page 88 - ITPS-8-1

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

study, Afshar et al. (n = 48) found that the total Y-BOCS for NAC from weeks 3 to 10 was 2,400 mg/day (1,200 mg
score of the NAC group decreased by 10.9 points, whereas bd). Two sets of random numbers were assigned as patient
that of the placebo group decreased by 5.7 points (P = code numbers. One set was designated as the intervention
0.003). Paydary et al. conducted a 10-week study in which arm, whereas the other set was the control arm.
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44 patients with OCD who had stopped taking psychiatric Eligible patients were newly diagnosed patients
medicines 6 weeks earlier were randomized to receive aged ≥18 years. Only patients with SSRIs (fluoxetine,
200 mg/daily fluvoxamine + placebo or 200 mg/daily sertraline, or fluvoxamine)-treated OCD who met
fluvoxamine plus 2 g/daily of NAC. According to Paydary the DSM-5 criteria and had a Y-BOCS score of ≥16
et al. (2016), the NAC augmentation group experienced (moderate-to-severe) were enrolled. The Y-BOCS scale
a higher slope of treatment response than the placebo is considered the gold-standard clinician-rated scale with
augmentation group (P = 0.012). In contrast, Sarris et al. subtotals for the degree of obsessions and compulsions.
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(n = 44) and Costa et al. (n = 40) reported that NAC is Each item is evaluated from 0 (no symptoms) to 4 (severe
not beneficial on the overall Y-BOCS scores by the study symptoms). The total score of 0 – 40, with separate
endpoint, despite having longer trial lengths and greater subscales for obsessions and compulsions. Patients who
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NAC dosages (16-week trials with a 3 g/day dosage). 49,51 had a history of any other psychiatric disorders and/or
Sarris et al. found no table improvements favoring NAC medical conditions before exposure to NAC within the
on the “compulsions” subscale of Y-BOCS at week12. last 2 months and those who did not provide consent
Compared with placebo, another study did not find were excluded from the study.
evidence that the use of NAC as an augmentation therapy
mitigated the OCD symptoms. In a case series and case 2.2. Outcomes
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report of patients with OCD treated with SSRIs and NAC, The primary outcome measure was the reduction of OCD
the Y-BOCS score decreased, and symptoms improved severity from baseline to after 10 weeks measured by
considerably. 53,54 Further studies with larger sample Y-BOCS-10. Secondary outcome measures were the safety
sizes are needed considering the conflicting findings and tolerability evaluations of NAC by serum alanine
from previous RCTs of NAC for OCD. In addition, long aminotransferase (ALT), aspartate aminotransferase
trial periods might be necessary to identify the possible (AST), creatinine, and electrocardiography (ECG) for
advantages of NAC. These results suggest that NAC can evaluating the liver, kidney, and heart functions at baseline
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effectively supplement the existing first-line treatments for and after 10 weeks that NAC was given at a high dose.
OCD. NAC has been proposed as a practical augmentation
due to its low cost and excellent tolerability, particularly 2.3. Study procedure
in the refractory subset of patients with OCD, in which
insufficient responses are noted and few alternatives are The enrollment and recruitment of patients were performed
available. Even at very high dosages, NAC was reportedly according to the principle of Consolidated Standards of
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safe. Thus, this randomized, double-blind, placebo- Reporting Trials. NAC, 600 mg effervescent tablets, and
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controlled study aimed to assess the safety and effectiveness placebo tablets were purchased from the Unimed and
of NAC as a glutamate-modulating drug in patients with Unihealth Manufacturers (Dhaka, Bangladesh) at the
moderate-to-severe OCD who were using SSRIs. original market price.
2. Materials and methods 2.4. Randomization and masking
Randomization was performed by online graph pad
2.1. Study design and participants software using a computer. After providing the necessary
Patients with moderate-to-severe OCD were recruited inputs (sample size and number sets), the software generates
from the outpatient departments of Bangabandhu Sheikh two distinct sets of random numbers. The calculated
Mujib Medical University (BSMMU) and Combined number of samples was randomly allocated in two arms.
Military Hospital (CMH), Dhaka, and participated in this Subsequently, the set of code numbers that belong to the
randomized, double-blind, placebo-controlled, 10-week intervention arm was written as patient code numbers on
multi-center trial from March 2020 to January 2022. the packages containing NAC tablets. Conversely, the set
A total of 60 patients were recruited, with 30 patients in the belonging to the control arm was designated as patient
intervention and 30 in the control arms. Patients in the two code numbers on the packages containing placebo tablets.
arms randomly received SSRIs plus placebo (2,400 mg/ The entire randomization process was performed by
day) and SSRIs plus NAC (2,400 mg/day). The dose of people unrelated to this research. Thus, the participants,
NAC at week 1 was 600 mg/day, which was increased to outcome assessor, and analyst were unaware of the received
1,200 mg/day in two divided doses at week 2. The daily dose treatment.

Volume 8 Issue 1 (2025) 82 doi: 10.36922/itps.4887