Effect of adding clonidine versus placebo to the standard treatment in patients with bipolar disorder during manic episode

Effect of adding clonidine versus placebo to the standard treatment in patients with bipolar disorder during manic episode: a double-blind randomized clinical trial

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT20120215009014N295

Enrollment

Registered

2019-09-14

Start date

2019-09-23

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 disorder during manic episode. Bipolar disorder, current episode hypomanic

Interventions

Intervention 1: Intervention group: Standard treatment plus tablet clonidine 0.2 mg one to three times a day (depending on the severity of the disease) for 24 days. Intervention 2: Control group: Stan

Eligibility

Sex/Gender

All

Age

18 Years to 65 Years

Inclusion criteria

Inclusion criteria: Age of 18 to 65 years Bipolar disorder during manic episode Need hospitalization Young score of 20 or higher

Exclusion criteria

Exclusion criteria: Pregnancy or breastfeeding Sensitivity to lithium or alpha-2 adrenergic receptor stimulants History of suicide, homicide, or suicidal intention History of drug abuse History of using anticholinergic or antidepressant three-cyclic drugs

Design outcomes

Primary

Measure	Time frame
Assessing sleep quality. Timepoint: Before the intervention and 12 and 24 days after the intervention. Method of measurement: By using Pittsburg Sleep Quality Index (PSQI).;Assessing the cognitive status. Timepoint: Before the intervention and 12 and 24 days after the intervention. Method of measurement: By using Montreal Cognitive Assessment (MOCA) and Mini Mental State Examination (MMSE).	—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactDr Rana Pezeshki

Hamedan University of Medical Sciences

r.pezeshki89@gmail.com+98 81 3827 4184

Outcome results

None listed

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