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Cognitive and negative symptoms in schizophrenia with L-Carnosine adjuvant therapy - A randomized double-blind placebo-controlled study.

  • 2023-03-22
  • Pharmacology research & perspectives 11(2)
    • Hema Tharoor
    • Sindhu Maran
    • Antra K Chandan
    • Manikandan Pari
    • Shruti Rao
    • Jothilakshmi Durairaj

Study Design

Type
Randomized Controlled Trial (RCT)
Population
100 eligible patients with predominant negative symptoms as measured by scale for assessment of negative symptoms (SANS total score ≥ 60) and Schizophrenia diagnosis (International Classification of Disorder-Tenth Edition, ICD-10)
Methods
Randomized double-blind placebo-controlled study; fixed dose of either 400 mg L-Carnosine or identical placebo for 3 months and increased to 800 mg from 13th week till completion of study
Blinding
Double-blind
Duration
24 weeks
Funding
Unclear
The antioxidant L-Carnosine is reported to improve negative and cognitive symptoms in Schizophrenia. A randomized double-blind placebo-controlled study was planned to study the effectiveness of adjuvant L-Carnosine therapy in patients with Schizophrenia. 100 eligible patients with predominant negative symptoms as measured by scale for assessment of negative symptoms (SANS total score ≥ 60) and Schizophrenia diagnosis (International Classification of Disorder-Tenth Edition, ICD-10) were recruited. They were randomly allocated to receive a fixed dose of either 400 mg L-Carnosine or identical placebo for 3 months and increased to 800 mg from 13th week till completion of study. Primary outcome measures assessed changes in SANS scores with L-Carnosine at 24 weeks compared to baseline, 4 and 12 weeks. Secondary outcome measures were done to assess the improvement in cognitive symptoms (executive function, attention, and memory) at 24 weeks using subtests of NIMHANS (National Institute for Mental Health and Neurosciences) cognitive battery. Side effects were assessed using adverse events reporting form. The attention scores (p = .023) showed significant differences in patients receiving 800 mg of L-Carnosine at the end of the study. There were no significant differences in negative symptoms in the two arms at study completion. L-Carnosine dosing of 800 mg may be a promising agent to enhance executive functions in Schizophrenia.

Research Insights

  • L-Carnosine→Improved Attention Score

    The attention scores (p = .023) showed significant differences in patients receiving 800 mg of L-Carnosine at the end of the study.

    Effect
    Beneficial
    Effect size
    Small
    Dose
    400 mg/day for first 3 months, then 800 mg/day from week 13 to week 24
  • L-Carnosine→Improved Cognitive Function

    The attention scores (p = .023) showed significant differences... L-Carnosine dosing of 800 mg may be a promising agent to enhance executive functions in Schizophrenia.

    Effect
    Neutral
    Effect size
    Small
    Dose
    400 mg/day for first 3 months, then 800 mg/day from week 13 to week 24
  • L-Carnosine→Improved Memory Function

    Secondary outcome measures were done to assess the improvement in cognitive symptoms (executive function, attention, and memory) at 24 weeks using subtests of NIMHANS cognitive battery.

    Effect
    Neutral
    Effect size
    Small
    Dose
    400 mg/day for first 3 months, then 800 mg/day from week 13 to week 24
  • L-Carnosine→Reduced Negative Symptoms

    There were no significant differences in negative symptoms in the two arms at study completion.

    Effect
    Neutral
    Effect size
    Small
    Dose
    400 mg/day for first 3 months, then 800 mg/day from week 13 to week 24
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