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Comparing the effect of lithium and placebo on premenstrual dysphoric disorder symptoms

Comparing the effect of lithium and placebo on premenstrual dysphoric disorder symptoms, a double-blind clinical trial

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20251217068367N1
Enrollment
60
Registered
2026-01-28
Start date
2026-04-03
Completion date
Unknown
Last updated
2026-02-02

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

Conditions

Premenstrual Dysphoric Disorder.

Interventions

Intervention 1: Intervention group: patient will be treated with 300-600 mg lithium carbonate for 7 days before the menstrual cycle, through the cycle, and for 5 days after. Intervention 2: Control gr

Sponsors

University of social welfare and rehabilitation sciences
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 45 Years

Inclusion criteria

Inclusion criteria: Women of reproductive age (18–45 years) with a diagnosis of Premenstrual Dysphoric Disorder (PMDD) according to DSM-5-TR criteria. Willingness to avoid pregnancy during the duration of the research No use of psychotropic medications within the past three months, unless in accordance with the study protocol No use of medications with known Lithium interactions within the past four weeks, unless discontinued under medical supervision

Exclusion criteria

Exclusion criteria: Women aged younger than 18 or older than 45 years Pregnancy or intention to conceive. Severe psychiatric condition or emergency requiring immediate intervention that precludes adherence to the study protocol. Known significant cardiac disease (e.g., arrhythmia, heart failure, or known Brugada syndrome). Known neurological disease or significant intellectual disability. Untreated hypothyroidism. Severe symptomatic anemia Known hepatic disease. Known renal disease. History of psychiatric hospitalization within the past year.

Design outcomes

Primary

MeasureTime frame
Change in symptom severity of Premenstrual Dysphoric Disorder. Timepoint: Daily. Method of measurement: Record of Severity of Problems with DRSP questionure.

Countries

Iran (Islamic Republic of)

Contacts

Public Contactsetareh zargar

University of social welfare and rehabilitation sciences

setare.zargar@yahoo.com33401220-9(021)

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 7, 2026