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Efficacy of Adding Folic Acid to Sodium Valproate on patients with Acute Mania

Compare Effectiveness of Adding Folic Acid to Sodium Valproate in Treating patients with Acute Mania

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20180103038196N2
Enrollment
60
Registered
2018-06-07
Start date
2018-02-20
Completion date
Unknown
Last updated
2018-07-16

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

Conditions

Acute Mania. Bipolar disorder, current episode manic without psychotic features

Interventions

Intervention 1: Intervention group: patients receiving folic acid + sodium valproate .Sodium valproate starts at 400 mg per day and will increase up to maximum of 20 mg per kg per day or the highest

Sponsors

Gorgan University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 50 Years

Inclusion criteria

Inclusion criteria: Being at the age of 18 to 50 years Diagnosis of type 1 bipolar disorder, being in mania episode based on diagnostic criteria DSM-5 (By a semi-structured interview by a psychiatrist and diagnosis based on minimum score 20 from the Young Mania Rating Scale)

Exclusion criteria

Exclusion criteria: Intolerance to increase the dose of the drug over a specified period of time. Presence of anemia Abnormal folic acid levels Changing the diagnosis and rejection of the initial diagnosis during the course of treatment History of ADHD psychiatric diagnosis combined with medication and other diseases history of admission to the psychiatric hospital during the past three months, Positive pregnancy test in women receive other medications, such as anti-mania treatments, two weeks prior to study or during the study history of sodium valproate sensitivity

Design outcomes

Primary

MeasureTime frame
Improvement of acute mania based on the results of the used tests. Timepoint: The beginning of the study (before the intervention) and 3 and 6 weeks after the intervention. Method of measurement: Young Mania Rating Scale and Mini-Mental State Examination 1.

Countries

Iran (Islamic Republic of)

Contacts

Public Contact??Dr Peyman Rad

Gorgan University of Medical Sciences

salimia92@gmail.com+98 17 3242 1651

Outcome results

None listed

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