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A Comparison of Adjunctive Quetiapine Versus Adjunctive Haloperidol in Combination with Sodium Valproate for Treatment of Patients with Bipolar I Disorder

A Comparison of Adjunctive Quetiapine Versus Adjunctive Haloperidol in Combination with Sodium Valproate for Treatment of Patients with Mania or Mixed Feature Bipolar I Disorder

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20150221021168N3
Enrollment
40
Registered
2021-05-06
Start date
2021-05-22
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 Mood Disorder with Mania or Mixed feature. Bipolar disorder, current episode manic without psychotic features, severe Bipolar disorder , current episode mixed

Interventions

Intervention 1: First Intervention group: Patients with bipolar 1 disorder with the most recent episode of mania or mixed feature

Sponsors

University of social welfare and rehabilitation sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: Patients of 18 years or above Patients were diagnosed with Bipolar I disorder experiencing an episode of acute mania or mixed feature according to psychiatric interview All participants voluntarily provided a written informed consent form

Exclusion criteria

Exclusion criteria: History of Sensitivity to Sodium Valproate , Quetiapine and Haloperidol History of Neurological , Cardiovascular , Respiratory, Blood , kidney, Hepatic , Endocrine, Immunological and other Systemic Disease Pregnancy and Breastfeeding Period HIV Positive and Uncontrolled Diabetic patients Substance Use Disorders History of Brain Blood Vessels Diseases and Head Trauma

Design outcomes

Primary

MeasureTime frame
The relevant mania score obtained by the Young Mania Rating Scale. Timepoint: The assessment of treatment response prior the beginning of the study, as well as 3 and 6 weeks after the study onset. Method of measurement: Young Mania Rating Scale.

Secondary

MeasureTime frame
The extent of drowsiness. Timepoint: Three and six weeks after the onset of the study. Method of measurement: The Epworth Sleepiness Scale.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactGita Sadighi

University of social welfare and rehabilitation sciences

g_sadighi_md@yahoo.com+98 21 3340 1604

Outcome results

None listed

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