The effect of quetiapine in children and adolescents with bipolar I disorder

Comparison of the effect of lithium plus quetiapine with lithium plus risperidone in children and adolescents with bipolar Idisorder (manic or mixed episode) in a double blind randomized clinical trial

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

IRCT

Registry ID

IRCT201205059645N1

Enrollment

Registered

2012-10-29

Start date

2012-07-22

Completion date

Unknown

Last updated

2018-02-22

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

Conditions

Bipolar disorder type I, manic or mixed episode. Bipolar affective disorder, current episode manic without psychotic symptoms, Bipolar affective disorder, current episode manic with psychotic symptoms, Bipolar affective disorder, current episode mixed

Interventions

Intervention 1: Intervention: lithium plus quetiapine up to 600 mg. Intervention 2: control: lithium plus risperidone up to 6mg.

Treatment - Drugs

Intervention: lithium plus quetiapine up to 600 mg

control: lithium plus risperidone up to 6mg

Eligibility

Sex/Gender

All

Age

10 Years to 17 Years

Inclusion criteria

Inclusion criteria: Inclusion criteria: ages 10-17 with bipolar I disorder, manic or mixed episode Exclusion criteria: YMRS score < 20 ( young mania rating scale); mood symptoms secondary to substance intoxication or withdrawal; substance use disorders 3 months prior to study; mental retardation; severe medical diseases; serious neurologic disorders; autistic disorder; history of hypersensitivity or intolerance or nonresponse to quetiapine or risperidone or lithium; use of long acting antipsychotics 3 months prior to study; use of antidepressants or antipsychotics 1 week prior to study; use of psychostimulants or benzodiazepines 72 hours prior to study

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

Measure	Time frame
Severity of manic or mixed episode. Timepoint: every two weeks. Method of measurement: Young Mania Rating Scale and Children's Depression Rating Scale.	—

Secondary

Measure	Time frame
Psychotic symptoms. Timepoint: every two weeks. Method of measurement: positive and negative syndrome scale - positive subscale.;General improvement. Timepoint: every two weeks. Method of measurement: clinical global impression-Improvement.;General functioning. Timepoint: baseline and endpoint. Method of measurement: children's global assessment scale.;Extrapyramidal side effects. Timepoint: weeks 1,2,4,6. Method of measurement: simpson-angus extrapyramidal side effects scale, barnes akathisia scale, abnormal involuntary movement scale.;Other side effects. Timepoint: weeks 1, 2, 4, 6. Method of measurement: side effects checklist.	—

Measure

Time frame

Psychotic symptoms. Timepoint: every two weeks. Method of measurement: positive and negative syndrome scale - positive subscale.;General improvement. Timepoint: every two weeks. Method of measurement: clinical global impression-Improvement.;General functioning. Timepoint: baseline and endpoint. Method of measurement: children's global assessment scale.;Extrapyramidal side effects. Timepoint: weeks 1,2,4,6. Method of measurement: simpson-angus extrapyramidal side effects scale, barnes akathisia scale, abnormal involuntary movement scale.;Other side effects. Timepoint: weeks 1, 2, 4, 6. Method of measurement: side effects checklist.

—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactNastaran Habibi

University of Social Welfare and Rehabilitation Sciences

na.habibi@uswr.ac.ir+98 21 2218 0083

Outcome results

None listed

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