Risperidone Plus Mood Stabilizer in Treatment of Mixed Mania

Completed · Phase 4

Conditions studied: Bipolar Disorder

In brief

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.

Key facts

Study ID

NCT00294255

Run by

The University of Texas Health Science Center at San Antonio

People needed

45

Starts

2003-03-01

Expected to finish

2006-10-01

Last updated by the study team

2018-06-14

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• DSM IV diagnosis of bipolar disorder, currently manic, or mixed manic
• YMRS score>/= 16
• One or more of following:
• 3 MADRS depression items scoring >/=3
• 3 BISS depression items scoring >/=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

Where it is running

• University of Texas Health Science Center — San Antonio, Texas, United States

Full record on ClinicalTrials.gov

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