Risperidone Plus Mood Stabilizer in Treatment of Mixed Mania

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:

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