Pentoxifylline for the treatment of mania

Effect of Pentoxifylline on the acute phase of mania: A randomized, double-blind, placebo-controlled trial

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT20090117001556N157

Enrollment

Registered

2024-04-10

Start date

2024-05-21

Completion date

Unknown

Last updated

2024-05-27

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: Control group: Patients receive 900 mg of lithium and up to 3 mg of risperidone daily, and placebo twice per day for six weeks. Intervention 2: Intervention group: Patients receive 900

Eligibility

Sex/Gender

All

Age

18 Years to 55 Years

Inclusion criteria

Inclusion criteria: Diagnosis of bipolar disorder based on DSM-V criteria Age between 55-18 years The score of 20 (at least) based on Young Mania Rating Scale

Exclusion criteria

Exclusion criteria: Systemic disease including hypothyroidism or hyperthyroidism Cardiac conduction disorder Drug dependence except nicotine and caffeine Presence of serious suicide risk IQ less than 70 History of allergy to any of the used drugs Pregnant and lactating women The use of drugs that cause symptoms similar to mania like psychostimulants

Design outcomes

Primary

Measure	Time frame
The severity of manic phase symptoms. Timepoint: Weeks: 0 - 2 - 4 - 6. Method of measurement: By Young Mania Rating Scale (YMRS).	—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactDr. 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