The effect of spironolactone as adjunctive therapy on the improvement of cognitive symptoms and mania

The effect of spironolactone as adjunctive therapy on the improvement of cognitive symptoms and mania(sleep , appetite) of type 1 bipolar disorder in randomized, double-blind, placebo-controlled clinical trial

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT20190316043072N2

Enrollment

Registered

2021-04-29

Start date

2021-04-21

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: Taking valproate Sodium tablet (200 mg), 3 times daily with spironolactone tablet (50 mg) , Daily for 8 weeks. Intervention 2: Control group: Taking valproate S

Eligibility

Sex/Gender

All

Age

18 Years to 55 Years

Inclusion criteria

Inclusion criteria: Having DSM-V diagnostic criteria for patients with bipolar disorder with mania phase Age 18 to 50 years Their minimum score is 14 based on Young Mania Rating Scale (YMRS)

Exclusion criteria

Exclusion criteria: Neurological disease Cardiovascular and hepatic disease IQ less than 70 Drug abuse (except nicotine and caffeine) pregnancy Taking drugs that interfere with spironolactone .

Design outcomes

Primary

Measure	Time frame
Mood symptoms. Timepoint: Before and after the intervention. Method of measurement: Young Mania Rating Scale (YMRS), Mini-Mental State Examination (MMSE).;Sleep quality improvement. Timepoint: Before and after the intervention. Method of measurement: Pittsburgh Sleep Quality Index (PSQI).	—

Secondary

Measure	Time frame
Appetite quality improvement. Timepoint: Before and after the intervention. Method of measurement: Simple appetite questionnaire.	—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactDr. Atefe Zandifar

Karaj University of Medical Sciences

zandifaratefe@gmail.com+98 32563328026

Outcome results

None listed

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