Risperidone Plus Mood Stabilizer in Treatment of Mixed Mania



Status:Completed
Conditions:Psychiatric, Bipolar Disorder
Therapuetic Areas:Psychiatry / Psychology
Healthy:No
Age Range:18 - Any
Updated:6/16/2018
Start Date:March 2003
End Date:October 2006

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Trial Summary
Trial Overview
Inclusion Criteria

Risperidone Plus Mood Stabilizer in the Treatment of Mixed Mania

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.

- 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.

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:
We found this trial at
1
site
University of Texas Health Science Center
San Antonio, Texas 78229
?
mi
from
San Antonio, TX
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