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Palmitoylethanolamide in the treatment of major depression

Palmitoylethanolamide as adjuvant therapy in the treatment of major depression: a randomised and double blind study

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
IRCT
Registry ID
IRCT201702181556N97
Enrollment
50
Registered
2017-02-20
Start date
2017-03-05
Completion date
Unknown
Last updated
2018-02-22

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

Conditions

Major Depressive Disorder. Major Depressive Disorder

Interventions

Intervention 1: Tablet Citalopram 40 mg/day plus Capsule palmitoylethanolamide 600 mg BID as intervention group for 6 weeks. Intervention 2: Tablet Citalopram 40 mg/day plus Capsule placebo as control
Treatment - Drugs
Placebo
Tablet Citalopram 40 mg/day plus Capsule palmitoylethanolamide 600 mg BID as intervention group for 6 weeks
Tablet Citalopram 40 mg/day plus Capsule placebo as control group for 6 weeks

Sponsors

Tehran University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 50 Years

Inclusion criteria

Inclusion criteria: Inclusion criteria: presence of Major Depressive Disorder based on DSM-5 criteria; baseline Hamilton Depression Rating Scale (HAM-D) (17-item) score of at least 19. Exclusion criteria: presence of psychosis, any other diagnosis in axis I and II; receiving psychotropic medications; receiving any antidepressants during past one month or ECT during past two months; presence of hypothyroidism or cardiovascular problems, pregnancy or nursing women.

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

MeasureTime frame
Severity of depression. Timepoint: Baseline and weeks 2,4 and 6. Method of measurement: by Hamiltion Depression Rating Scale 17-Item.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactProf. Shahin 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