Effect of levetiracetam versus placebo on the clinical signs of in bipolar patients in the manic episode

Effect of levetiracetam versus placebo on the clinical signs of in bipolar patients in the manic episode: a double-blind randomized clinical trial

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

IRCT

Registry ID

IRCT20120215009014N293

Enrollment

Registered

2019-09-13

Start date

2019-10-02

Completion date

Unknown

Last updated

2019-10-07

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

Conditions

Bipolar patients in the manic episode. Bipolar disorder, current episode manic severe with psychotic features

Interventions

Intervention 1: Intervention group: Standard treatment plus tablet levetiracetam 250 mg three times daily for 28 days. Intervention 2: Control group: Standard treatment plus tablet placebo three times

Eligibility

Sex/Gender

All

Age

16 Years to 65 Years

Inclusion criteria

Inclusion criteria: Age of 16 to 65 years, Bipolar disorder in the manic phase, Young score =20

Exclusion criteria

Exclusion criteria: Bipolar disorder in the depressive phase

Design outcomes

Primary

Measure	Time frame
Clinical signs. Timepoint: Before the intervention and 14 and 28 days after that. Method of measurement: Using the Young Mania Rating Scale (YMRS).;Sleep quality. Timepoint: Before the intervention and 14 and 28 days after that. Method of measurement: Using the Pittsburgh Standard Questionnaire.;Cognitive function. Timepoint: Before the intervention and 14 and 28 days after that. Method of measurement: Using the Montreal Cognitive Assessment (MoCA).	—

Measure

Time frame

Clinical signs. Timepoint: Before the intervention and 14 and 28 days after that. Method of measurement: Using the Young Mania Rating Scale (YMRS).;Sleep quality. Timepoint: Before the intervention and 14 and 28 days after that. Method of measurement: Using the Pittsburgh Standard Questionnaire.;Cognitive function. Timepoint: Before the intervention and 14 and 28 days after that. Method of measurement: Using the Montreal Cognitive Assessment (MoCA).

—

Secondary

Measure	Time frame
Gastric complications. Timepoint: 28 days after the intervention. Method of measurement: By history taking.	—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactDr Aziz Sharifi

Hamedan University of Medical Sciences

azizsharifi91@gmail.com+98 81 3827 4184

Outcome results

None listed

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