Risperidone Plus Mood Stabilizer in Treatment of Mixed Mania

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

45 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-03-31

Study Completion Date

2006-10-31

Brief Summary

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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.

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Detailed Description

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* 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.

Conditions

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Bipolar Disorder

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Risperidone

patients will receive risperidone for up to 20 weeks

Group Type EXPERIMENTAL

Risperidone

Intervention Type DRUG

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

Interventions

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Risperidone

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

Intervention Type DRUG

Other Intervention Names

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risperdal

Eligibility Criteria

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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