The effect of Palmitoylethanolamide on the treatment of mania

The effect of Palmitoylethanolamide on acute phase of mania: A randomized double blind and placebo controlled clinical trial

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT20090117001556N135

Enrollment

Registered

2021-05-03

Start date

2021-05-22

Completion date

Unknown

Last updated

2021-05-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bipolar disorder. Bipolar disorder

Interventions

Intervention 1: Intervention group: Patients treated with lithium 900mg and risperidone 3mg and Palmitoylethanolamide 600mg twice per day. Intervention 2: Control group: Patients treated with lithium

Eligibility

Sex/Gender

All

Age

18 Years to 54 Years

Inclusion criteria

Inclusion criteria: Meeting the DSM-IV criteria for Bipolar Disorder-manic episode Age between 18 to 54 years old Score of at least 20 on Young Mania Rating Scale

Exclusion criteria

Exclusion criteria: Hyper- or hypothyroidism Substance dependence (except Nicotine and Caffeine) IQ lower than 70 Lactating or pregnant women Severe hepatic disease

Design outcomes

Primary

Measure	Time frame
Severity of mania. Timepoint: Baseline and weeks: 2, 4, 6. Method of measurement: Using Young Mania Rating Scale.	—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactShahin Akhondzadeh

Tehran University of Medical Sciences

s.akhond@sina.tums.ac.ir+98 21 5541 2222

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026