Iloperidone in Mixed States of Bipolar Disorder

Completed · Phase 4

Conditions studied: Bipolar Disorder

In brief

1. To assess the acute and long-term bimodal efficacy of iloperidone (IL), as an adjunct to ongoing treatment with lithium (Li) or divalproex (DIV) or lamotrigine (LAM) or any combination of the three thereof, in a group of patients with an index episode of a mixed state in BD. 2. To assess background, baseline features, and behavioral components which characterize treatment response/non-response in the acute and long term management of MS

Key facts

Study ID

NCT02413918

Run by

The University of Texas Health Science Center at San Antonio

People needed

41

Starts

2012-04-01

Expected to finish

2015-04-01

Last updated by the study team

2018-02-08

Who can join

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

You may qualify if…

• Male or female;
• Age 18 years and older
• Patients on:
• Li at a stable dose for 2 weeks or longer, and a serum level at screening of greater than or equal to 0.5 mEq/l OR
• DIV dose for 2 weeks or longer, and a serum level at screening of greater than or equal to 45 ug/ml OR
• LAM (dosage/day ≥100mg) at a stable dose for 2 weeks or longer OR
• Any combination 3a, 3b, or 3c
• Patients meeting DSM-IV TR diagnosis of bipolar disorder, I or II, as assessed using the MINI, (Sheehan et al., 1998) PLUS any ONE of criteria 5 or 6 or 7
• Patients meeting DSM-IV TR diagnostic criteria for a mixed manic episode with Young Mania Rating Scale (YMRS) score>/=14 and Montgomery Asberg Depression Rating Scale (MADRS) score>/=14
• Patients meeting the criteria for a manic/hypomanic episode for at least 2 days with the simultaneous presence of Young Mania Rating Scale (YMRS) score>/=14 PLUS Montgomery Asberg Depression Rating Scale (MADRS) score>/=14 ;
• Patients meeting DSM-IV TR diagnostic criteria for a major depressive episode with the simultaneous presence of MADRS score>/=14 PLUS meeting the criteria for a manic/hypomanic episode for at least 2 days with the simultaneous presence of Young Mania Rating Scale (YMRS) score>/=14

You may not qualify if…

• Patients with a current Axis I diagnosis of schizophrenia, schizophreniform disorder, schizotypal disorder, bipolar disorder with psychotic sub-type that requires hospitalization, drug induced mania or AIDS induced mania
• Women with a positive pregnancy test or who are lactating
• Women of child-bearing potential who are not practicing a clinically accepted method of contraception
• Patients with general medical conditions that contraindicate psychoactive medications or uncontrolled medical disorder or central nervous system diseases.
• Patients whose clinical status requires inpatient or day hospital treatment
• History of severe side effects associated with therapeutic doses of Li, DIV, LAM
• Alcohol or drug dependent at time of enrollment
• Suicidal at time of enrollment.
• Current or previous exposure to iloperidone
• Patients taking medication that cause QTC prolongation
• Patients with serious cardiac disease

Where it is running

• UT Health Science Center San Antonio — San Antonio, Texas, United States

Full record on ClinicalTrials.gov

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