Risperidone Plus Mood Stabilizer in Treatment of Mixed Mania

Risperidone Plus Mood Stabilizer in the Treatment of Mixed Mania

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00294255

Enrollment

Registered

2006-02-20

Start date

2003-03-31

Completion date

2006-10-31

Last updated

2018-06-14

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

Conditions

Bipolar Disorder

Keywords

mixed mania, depression, irritability

Brief summary

The study aims to assess the efficacy and tolerability of risperidone added to lithium, valproate or lamotrigine in patients experiencing a manic episode with depressive or irritable features.

Detailed description

* The study aims to assess the efficacy and tolerability of risperidone added to lithium, valproate or lamotrigine, or any combination of the three, in patients experiencing a manic episode with depressive or irritable symptoms. * To assess the back ground and baseline features associated with response/non-response to risperidone plus mood stabilizer in patients with mania with depressive or irritable features. * To assess the symptomatic dimensions of response of risperidone added to mood stabilizers in patients with mania with depressive or irritable features.

Interventions

DRUGRisperidone

risperidone will be administered 1-3mg pills, each night, for up to 20 weeks

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* DSM IV diagnosis of bipolar disorder, currently manic, or mixed manic * YMRS score\>/= 16 * One or more of following: 1. 3 MADRS depression items scoring \>/=3 2. 3 BISS depression items scoring \>/=3 3. YMRS irritability and aggressive items sum score\>/=4 * Taking lithium, valproate or lamotrigine at stable dose for 4 wks or longer, with adequate serum level * age 18 and over * Male or female * Inpatient or outpatient

Exclusion criteria

Design outcomes

Primary

Measure	Time frame
Forty percent reduction in YMRS	20 weeks

Secondary

Measure	Time frame
twenty percent reduction in MADRS	20 weeks
Remission rate, defined as final score of plus or minus eight on YMRS and MADRS	20 weeks

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026