Iloperidone in Mixed States of Bipolar Disorder

NCT02413918 | Completed Phase 4 Results DMC

• 1 other identifier: HSC20120137
• Study Type: interventional
• Target: 41
• Locations: 1 country
• Sites: 1

Brief Summary

1. 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. 2.To assess background, baseline features, and behavioral components which characterize treatment response/non-response in the acute and long term management of MS

Conditions

Bipolar Disorder

Keywords

mixed episode

Outcome Measures

Primary Outcomes (1)

• Measure of Response by Change From Baseline to End of Study in BISS Depression and Mania Scale Scores

  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

Study Arms (1)

Open Label iloperidone

EXPERIMENTAL

open label iloperidone (oral tablet, 6mg-24mg, QD, 20 weeks) as adjunct to current lithium, divalproex, or lamotrigine.

Drug: iloperidone

Interventions

iloperidone DRUG

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.

Also known as: Fanapt

Open Label iloperidone

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• The University of Texas Health Science Center at San Antonio: lead
• Novartis Pharmaceuticals: collaborator
• Vanda Pharmaceuticals: collaborator

Study Sites (1)

UT Health Science Center San Antonio

San Antonio, Texas, 78229, United States

Location

MeSH Terms

Conditions

Bipolar Disorder

Interventions

iloperidone

Condition Hierarchy (Ancestors)

Bipolar and Related Disorders; Mood Disorders; Mental Disorders

Results Point of Contact

• Title: Charles Bowden, MD
• Organization: University of Texas HEalth Science Center San Antonio

BowdenC@uthscsa.edu

210-567-5405

Study Officials

• Charles Bowden, MD

  UT Health Science Center San Antonio

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 7, 2015
• First Posted: April 10, 2015
• Study Start: April 1, 2012
• Primary Completion: April 1, 2015
• Study Completion: April 1, 2015
• Last Updated: February 8, 2018
• Results First Posted: November 6, 2017

Record last verified: 2017-05

Locations

US (1)