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CompletedNCT00294255Updated Jun 14, 2018

Risperidone Plus Mood Stabilizer in Treatment of Mixed Mania

A Phase 4 interventional study of Risperidone in Bipolar Disorder, sponsored by The University of Texas Health Science Center at San Antonio. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-06-14.

Sponsored by The University of Texas Health Science Center at San Antonio · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
45
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study summary

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.

Read the detailed 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.
02

Conditions studied

  • Bipolar Disorder

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Keywords

  • mixed mania
  • depression
  • irritability
03

In context

Bipolar Disorder

1,601 studies on the registry are indexed under Bipolar Disorder; 254 are open to participants now.

This study's enrollment of 45 is below the median of 64 across 1,223 interventional studies indexed under Bipolar Disorder.

Browse Bipolar Disorder studies →

Lead sponsor

The University of Texas Health Science Center at San Antonio is the lead sponsor of 435 studies on the registry; 88 are open to participants now.

Of its 62 completed or terminated interventional studies of FDA-regulated products, 31 (50%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

Exclusion Criteria:

-

05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
45 participants (actual)

Study arms

  • Experimental
    Risperidone

    patients will receive risperidone for up to 20 weeks

    Drug: Risperidone

Interventions

  • DrugRisperidone

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

    Also known as: risperdal

06

What researchers measure

Primary outcomes

  1. Forty percent reduction in YMRS

    Time frame: 20 weeks

Secondary outcomes

  1. twenty percent reduction in MADRS

    Time frame: 20 weeks

  2. Remission rate, defined as final score of plus or minus eight on YMRS and MADRS

    Time frame: 20 weeks

07

Study locations

1 site
  • University of Texas Health Science Center
    San Antonio, Texas 78229, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 14, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00294255
Lead sponsor
The University of Texas Health Science Center at San Antonio
Collaborators
Janssen, LP
Responsible party
Sponsor
First posted
Feb 20, 2006
Start date
Mar 2003
Primary completion
Oct 2006
Completion
Oct 2006
Last update
Jun 14, 2018

Study contacts

Vivek Singh, MD
study director · UT-SanAntonio
Charles Bowden, MD
principal investigator · UT San Antonio

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2013. You cannot join it, but the record below documents what was studied.

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