Risperidone Plus Mood Stabilizer in Treatment of Mixed Mania

The University of Texas System (UT)

Status and phase: Completed; Phase 4

Conditions: Bipolar Disorder

Treatments: Drug: Risperidone

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00294255

RIS-USA-T290

Details and patient eligibility

About

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.

Full 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.

Enrollment: 45 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

45 participants in 1 patient group

Risperidone

Experimental group

Description:

patients will receive risperidone for up to 20 weeks

Treatment:

Drug: Risperidone