Efficacy and safety of palmitoylethanolamide as an adjunctive treatment for acute mania: A randomized, double-blind, placebo-controlled trial.
Amides
/ therapeutic use
Antimanic Agents
/ therapeutic use
Antipsychotic Agents
/ therapeutic use
Basal Ganglia Diseases
Bipolar Disorder
/ diagnosis
Double-Blind Method
Drug Therapy, Combination
Ethanolamines
Humans
Lithium
/ therapeutic use
Mania
Palmitic Acids
/ adverse effects
Psychiatric Status Rating Scales
Risperidone
Treatment Outcome
acute mania
bipolar disorder
neuroinflammation
palmitoylethanolamide
peroxisome proliferator-activated receptor
Journal
Psychiatry and clinical neurosciences
ISSN: 1440-1819
Titre abrégé: Psychiatry Clin Neurosci
Pays: Australia
ID NLM: 9513551
Informations de publication
Date de publication:
Oct 2022
Oct 2022
Historique:
revised:
07
06
2022
received:
02
04
2022
accepted:
19
06
2022
pubmed:
24
6
2022
medline:
12
10
2022
entrez:
23
6
2022
Statut:
ppublish
Résumé
Palmitoylethanolamide is an endogenous fatty acid amide with neuroprotective and anti-inflammatory actions. We performed a randomized, double-blind, placebo-controlled clinical trial to investigate the efficacy and safety of palmitoylethanolamide combination therapy in acute mania. Patients in the acute phase of mania were assigned into two parallel groups given either lithium (blood level of 0.8-1.1 mEq/L) and risperidone 3 mg plus palmitoylethanolamide 600 mg or placebo twice per day for 6 weeks. All participants were assessed with the Young Mania Rating Scale (YMRS), Hamilton Depression Rating Scale (HDRS), and Extrapyramidal Symptom Rating Scale (ESRS) at baseline and at weeks 1, 2, 4, and 6. A total of 63 patients (32 in palmitoylethanolamide and 31 in placebo groups) completed the trial. We found a significant effect for time×treatment interaction on the YMRS score (F = 5.22, d.f. = 2.34, P= 0.004) from baseline to study end point. Results from independent t test showed a significantly greater decrease in YMRS scores in the palmitoylethanolamide group, compared with the placebo group, from baseline to weeks 4 and 6 (P= 0.018 and P= 0.002, respectively). There was no significant difference between palmitoylethanolamide and placebo groups based on ESRS scores or ESRS changes in scores (P>0.05). Our findings provide preliminary evidence that palmitoylethanolamide is an effective adjunctive medication that improves manic symptoms and overall clinical status in acute episodes of mania. However, larger sample sizes and more extended follow-up therapy are needed in future studies to confirm our findings.
Substances chimiques
Amides
0
Antimanic Agents
0
Antipsychotic Agents
0
Ethanolamines
0
Palmitic Acids
0
palmidrol
6R8T1UDM3V
Lithium
9FN79X2M3F
Risperidone
L6UH7ZF8HC
Types de publication
Journal Article
Randomized Controlled Trial
Langues
eng
Sous-ensembles de citation
IM
Pagination
505-511Subventions
Organisme : Tehran University of Medical Sciences and Health Services
ID : 50780
Informations de copyright
© 2022 The Authors. Psychiatry and Clinical Neurosciences © 2022 Japanese Society of Psychiatry and Neurology.
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