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A randomized, placebo-controlled trial investigated the efficacy of fluoxetine augmented with scopolamine in reducing symptoms of premenstrual dysphoric disorder among patients aged 18-40

A randomized, placebo-controlled trial investigated the efficacy of fluoxetine augmented with scopolamine in reducing symptoms of premenstrual dysphoric disorder among patients aged 18-40

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20250219064776N1
Enrollment
65
Registered
2025-02-27
Start date
2025-03-05
Completion date
Unknown
Last updated
2025-07-21

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

Conditions

Premenstrual dysphoric disorder. Other specified mood [affective] disorders

Interventions

Intervention 1: Patients in this group receive fluoxetine boosted with scopolamine. Dosage: 0.5 mg scopolamine + fluoxetine, taken as 2 tablets per day. Objective: To investigate the effect of this dr

Sponsors

Zahedan University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 40 Years

Inclusion criteria

Inclusion criteria: Women aged 18 to 40 with premenstrual dysphoric disorder Informed consent to participate in the study No history of tobacco, caffeine, or alcohol use in the past month. No history of taking medications such as OCPs, antidepressants, analgesics, antispasmodics, and GnRH analogs in the past month. No history of uterine and ovarian diseases such as myomas, polycystic ovary syndrome, endometriosis, infections, polyps, and cancer. No history of uterine and ovarian diseases such as myomas, polycystic ovary syndrome, endometriosis, infections, polyps, and cancer. No history of surgical interventions such as hysterectomy and various methods of endometrial ablation or resection No history of using levonorgestrel-releasing intrauterine devices in the past month

Exclusion criteria

Exclusion criteria: Unwillingness to continue cooperation in any stage of the research Observation of serious side effects of hyoscine during research

Design outcomes

Primary

MeasureTime frame
Severity of premenstrual symptoms. Timepoint: Daily symptom recording form. Method of measurement: In the first interview, if the conditions for entry into the study are met, two questionnaires are filled out by the patient and the doctor, and then, depending on the menstrual cycle, they are checked again immediately after the end of the second cycle, between 42-70 days later.;Premenstrual dysphoric disorder score. Timepoint: Daily symptom recording form. Method of measurement: Standard PMDD screening questionnaire.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactMona Mahdavian

Zahedan University of Medical Sciences

m.mahdavian@zaums.ac.ir+98 54 3351 3778

Outcome results

None listed

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