L-Carnosine combination therapy for major depressive disorder: A randomized, double-blind, placebo-controlled trial.

2020-04
Journal of affective disorders 267
- Behin Araminia
- Mohammadreza Shalbafan
- Amirhosein Mortezaei
- Elham Shirazi
- Salomeh Ghaffari
- Erfan Sahebolzamani
- Seyyed Hosein Mortazavi
- Behnam Shariati
- Mehrdad Eftekhar Ardebili
- Ali Aqamolaei
- Sina Naderi
- Shahin Akhondzadeh

PubMed: 32063564
DOI: 10.1016/j.jad.2020.02.020

Study Design

Type: Randomized Controlled Trial (RCT)
Population: 58 patients with MDD (DSM-V) and Hamilton Depression Rating Scale (HAM-D) score ≥ 19
Methods: randomized double-blind, and placebo-controlled study, 400 mg twice daily L-Carnosine or placebo in addition to citalopram (maximum dosage of 40 mg/day) for six weeks
Blinding: Double-blind
Duration: six weeks

Background

Evidence for antidepressant effects of L-Carnosine was shown in some experimental studies. In this study we tried to evaluate the efficacy and tolerability of L-Carnosine combination therapy in treatment of patients with major depressive disorder (MDD).

Methods

Fifty-eight patients with MDD (DSM-V) and Hamilton Depression Rating Scale (HAM-D) score ≥ 19 were randomized to receive either 400 mg twice daily L-Carnosine or placebo in addition to citalopram (maximum dosage of 40 mg/day) for six weeks in a randomized double-blind, and placebo-controlled study. Patients were assessed using the HAM-D scale at baseline and weeks 2, 4, and 6.

Results

Fifty-two patients completed the trial. General linear model repeated measure showed significant difference for time × treatment on HAM-D score [F = 3.17, df = 2.39, p-value = 0.03]. Significantly greater improvement was detected in HAM-D score of the L-Carnosine group compared with the placebo group from baseline to weeks 2, 4 and 6 [Ps = 0.013, 0.028 and 0.023; respectively]. Patients in the L-Carnosine group experienced significantly greater response and remission rate than the placebo group [Ps = 0.023 and 0.012; respectively]. There was no significant difference between the two groups in baseline parameters and frequency of side effects.

Limitations

Short follow-up period and small population size were two important limitations of this study.

Conclusions

L-Carnosine combination therapy with citalopram can effectively improve symptoms of patients with major depressive disorder. Rapid-onset antidepressant effects of L-Carnosine were also shown which need further investigation.

Research Insights

L-Carnosine→Improved Remission Rate
Patients in the L-Carnosine group experienced significantly greater response and remission rate than the placebo group [Ps = 0.023 and 0.012; respectively].
Effect
Beneficial
Effect size
Moderate
Dose
400 mg twice daily
L-Carnosine→Improved Response to Treatment
Patients in the L-Carnosine group experienced significantly greater response and remission rate than the placebo group [Ps = 0.023 and 0.012; respectively].
Effect
Beneficial
Effect size
Moderate
Dose
400 mg twice daily
L-Carnosine→Reduced Depression Symptoms
General linear model repeated measure showed significant difference for time × treatment on HAM-D score [F = 3.17, df = 2.39, p-value = 0.03]. Significantly greater improvement was detected in HAM-D score of the L-Carnosine group compared with the placebo group from baseline to weeks 2, 4 and 6 [Ps = 0.013, 0.028 and 0.023; respectively].
Effect
Beneficial
Effect size
Moderate
Dose
400 mg twice daily

Adverse Events Reported

L-Carnosine→Overall tolerability
There was no significant difference between the two groups in baseline parameters and frequency of side effects.
Finding
No significant difference
Significant
No