Iloperidone in Mixed States of Bipolar Disorder

January 12, 2018 updated by: The University of Texas Health Science Center at San Antonio

Open Label Study of Iloperidone (IL) as Adjunctive Treatment in Mixed States (MS) of Bipolar Disorder (BD)

  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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This is a prospective 20-week, open-label study of iloperidone added to ongoing treatment regimen with mood stabilizers (Li or DIV or LAM or any combination of these) in the acute and maintenance treatment of MS- Total number of subjects: 40.

Severity of the illness and psychopathological features will be measured by the following rating scales: YMRS, MADRS, CGI-S and GAS, and the BISS .

The study will monitor the safety and tolerability of the combination iloperidone plus mood stabilizers.

Efficacy Measures: Primary efficacy measures include 1) Mixed effects repeat measure of change from baseline in BISS total score and, secondarily, manic and depression subscale scores.

Secondary Efficacy Measures: 1) response defined as 50% reduction in YMRS and MADRS and 2) Time to intervention or discontinuation for any mood episode.

Iloperidone will be initiated at 2 mg at hs on day 1 with increase to 4mg at hs on day 2, 8 mg at hs on day 3. All patients will have iloperidone titrated to receive a dosage of at least 12 mg a day. Dosages can be titrated up to 24 mg a day based on tolerability and clinical indication. Dosage of iloperidone can be reduced to 6 mg a day if patients develop side effects necessitating a reduction in the dosage

Study Type

Interventional

Enrollment (Actual)

41

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • San Antonio, Texas, United States, 78229
        • UT Health Science Center San Antonio

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Male or female;
  2. Age 18 years and older

  3. 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
  4. 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
  5. 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
  6. 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 ;
  7. 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

Exclusion Criteria:

  1. 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
  2. Women with a positive pregnancy test or who are lactating
  3. Women of child-bearing potential who are not practicing a clinically accepted method of contraception
  4. Patients with general medical conditions that contraindicate psychoactive medications or uncontrolled medical disorder or central nervous system diseases.
  5. Patients whose clinical status requires inpatient or day hospital treatment
  6. History of severe side effects associated with therapeutic doses of Li, DIV, LAM
  7. Alcohol or drug dependent at time of enrollment
  8. Suicidal at time of enrollment.
  9. Current or previous exposure to iloperidone
  10. Patients taking medication that cause QTC prolongation
  11. Patients with serious cardiac disease

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Open Label iloperidone
open label iloperidone (oral tablet, 6mg-24mg, QD, 20 weeks) as adjunct to current lithium, divalproex, or lamotrigine.
Drug: iloperidone
Qualifying subjects will take iloperidone starting at 2mg and up to a minimum of 12mg, maximum of 24mg, for 20 weeks in conjunction to the subjects current lithium, and or divalproex, and or lamotrigine.
Other Names:
  • Fanapt

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Measure of Response by Change From Baseline to End of Study in BISS Depression and Mania Scale Scores
Time Frame: Baseline and 20 weeks

The Bipolar Inventory of Symptoms Scale is a reliable and valid measure which assesses Depression and Mania symptoms of bipolar disorder. There are 42 items; each item is rated on a 0-4 scale. The BISS is a clinician-rated instrument. The Scale is rated as follows:

0 Not at all

  1. Slight
  2. Mild
  3. Moderate
  4. Severe Each of the 42 items is rated separately, with a score, based on the most recent 7 day period.

For Depression: Items 1-21 items of the assessment are summed up and multiplied by 4 to give a cumulative score out of 84. The higher the score, the more severe the depression.

For Mania: Items 22-42 are summed up and multiplied by 4 to give a cumulative score out of 84. The higher the score, the more severe the mania. The mean is calculated from the change in score between baseline and week 20.
Baseline and 20 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The University of Texas Health Science Center at San Antonio

Collaborators

Novartis Pharmaceuticals
Vanda Pharmaceuticals

Investigators

  • Principal Investigator: Charles Bowden, MD, UT Health Science Center San Antonio

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2012

Primary Completion (ACTUAL)

April 1, 2015

Study Completion (ACTUAL)

April 1, 2015

Study Registration Dates

First Submitted

April 7, 2015

First Submitted That Met QC Criteria

April 9, 2015

First Posted (ESTIMATE)

April 10, 2015

Study Record Updates

Last Update Posted (ACTUAL)

February 8, 2018

Last Update Submitted That Met QC Criteria

January 12, 2018

Last Verified

May 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HSC20120137

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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