Fingolimod in Schizophrenia Patients

NCT01779700 | Completed Phase 2 Results DMC

• 1 other identifier: 11T-001
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 3

Brief Summary

This will be a single site safety and proof of concept study conducted at the Indiana University Psychotic Disorders Program. Forty subjects with schizophrenia or schizoaffective disorders will be randomized 1:1 to double-blind treatment with fingolimod or matched placebo for duration of 8 weeks.

Conditions

Schizophrenia

Keywords

psychosis; schizophrenia; cognition; fingolimod

Outcome Measures

Primary Outcomes (3)

• QTcB Change

  To determine the safety of fingolimod, as measured by the electrocardiogram (ECG) QT interval corrected by Bazett's (QTcB) value.

  Screening, Day 0, Day 7, Day 14, Day 21, Day 28, Day 35, Day 42, Day 49, Day 56, Day 84, Day 112

• Levels of Lymphocyte

  To determine the safety of fingolimod, as measured by the absolute lymphocyte count

  Baseline, 4 weeks, 8 weeks

• Symptom Changes - PANSS Total Score

  The Positive and Negative Syndrome Scale (PANSS) is a semi-structured interview, containing 30 items that assess symptoms of psychotic disorders including positive, negative, and general psychopathology symptoms. Positive symptoms are rated on 7 items, negative symptoms are rated on 7 items, and general psychopathology on 16 items. Scores for each item range from 1=absent to 7=extreme. Positive, negative, and general psychopathology symptoms can each respectively render total scores. Positive total scores ranging from 7-49, negative total scores ranging from 7-49, and general psychopathology scores ranging from 16-112. When all items are summed together a total score is generated. Total scores for all items range from 30-210, a lower score reflecting fewer symptoms.

  Baseline, 4 weeks, 8 weeks

Secondary Outcomes (14)

• Verbal Memory - BACS

  Baseline, 4 weeks, 8 weeks

• Cognition Change - BACS

  Baseline, 4 weeks, 8 weeks

• Cognition Change - Trails B

  Baseline, 4 weeks, 8 weeks

• Positive Symptom Change - PANSS

  Baseline, 4 weeks, 8 weeks

• Negative Symptom Change - PANSS

  Baseline, 4 weeks, 8 weeks

Study Arms (2)

Fingolimod

ACTIVE COMPARATOR

0.5mg of fingolimod, oral administration, daily, for 8 weeks.

Drug: Fingolimod

placebo

PLACEBO COMPARATOR

placebo, oral administration, daily, for 8 weeks.

Drug: placebo

Interventions

Fingolimod DRUG

0.5mg each day of 8 week cycle

Also known as: gilenya

Fingolimod

placebo DRUG

1 tablet each day of 8 week cycle

Also known as: sugar pill

placebo

Eligibility Criteria

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

You may qualify if:

• to 65 yrs, able to give informed consent
• DSM IV-TR Diagnosis of schizophrenia or schizoaffective disorder
• Previous and/or current exposure to one of the following antipsychotic medications (clozapine, olanzapine, risperidone, paliperidone, haloperidol, quetiapine) as defined by a minimum of 8 weeks in duration greater than or equal to the Food and Drug Administration (FDA) approved therapeutic range for schizophrenia at the time of study entry OR previous and/or current exposure to two antipsychotic medications as defined by a minimum of 4 weeks in duration and greater than or equal to the FDA approved therapeutic range for schizophrenia at the time of study entry
• willing to participate in a minimum of 1 day of hospitalization
• Clinical stability:
• CGI-S score of \< 4 at randomization AND
• no exacerbation of illness within 4 weeks prior to randomization, leading to an intensification of psychiatric care in the opinion of the investigator AND
• antipsychotic treatment stability for at least 4 weeks prior to randomization
• Female subjects of childbearing potential must test negative for pregnancy at screening and agree to use a single, effective, medically acceptable method of birth control for the duration of the study and for two months following cessation of study medication
• Subjects must agree not to consume tonic water for the duration of the study and for two months following cessation of study medication
• Sub-optimally treated positive OR negative symptoms as defined by the Brief Psychiatric Rating Scale (BPRS):
• BPRS positive symptom factor (conceptual disorganization, hallucinations, suspiciousness, unusual thought content) score of \> 4 on any one item or a sum \> 8 on the factor
• BPRS negative symptom factor (motor retardation, blunted affect, inappropriate affect) score of \> 4 on any one item or a sum \> 6 on the factor

You may not qualify if:

• Subjects who are considered prisoners per the IU Standard Operating Procedures for Research Involving Human Subjects
• Current acute, serious, or unstable medical conditions
• Clinically significant electrocardiogram abnormality: corrected QT interval \>450 msec (M) or \>470 msec (F) prior to randomization OR sinus bradycardia (HR \< 50 beats/min)
• Subjects who have experienced the following within the six months prior to study entry: myocardial infarction, unstable angina, stroke, transient ischemic attach (TIA), decompensated heart failure requiring hospitalization or Class III/IV heart failure
• Hypokalemia, hypomagnesemia, or congenital long-QT syndrome
• Known HIV+ status
• Active seizure disorder
• Pregnant or lactating women or women who plan to become pregnant or will be lactating within two months after cessation of study drug
• Implanted pacemaker, medication pump, vagal stimulator, deep brain stimulator, TENS unit, ventriculoperitoneal shunt, or other contraindication to undergoing an MRI scan
• Class1a or class 3 antiarrhythmic agents, beta blockers, diltiazem, verapamil, digoxin, tricyclic antidepressants, warfarin, ketoconazole, ketamine
• Subjects likely to need a live attenuated vaccine during the course of the study or within two months after stopping study medication
• Subjects with no history of chicken pox or chicken pox vaccination, or with a negative VZV titer
• Active herpes simplex outbreak, mononucleosis, or zoster
• Subjects with histories of ischemic heart disease, myocardial infarction, congestive heart failure, cardiac arrest, cerebrovascular disease, unexplained or recurrent syncope, cardiac conduction prolongations (prolonged P-R interval), cardiac arrhythmias, symptomatic bradycardia, or severe untreated sleep apnea
• Antineoplastic, immunosuppressive, or immune modulating therapies

Sponsors & Collaborators

• Indiana University: lead

Study Sites (3)

Center for NeuroImaging

Indianapolis, Indiana, 46202, United States

Location

Prevention and Recovery Center

Indianapolis, Indiana, 46202, United States

Location

Larue D Carter Memorial Hospital

Indianapolis, Indiana, 46222, United States

Location

MeSH Terms

Conditions

Schizophrenia; Psychotic Disorders

Interventions

Fingolimod Hydrochloride; Sugars

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Sphingosine; Amino Alcohols; Alcohols; Organic Chemicals; Propylene Glycols; Glycols; Amines; Carbohydrates

Results Point of Contact

• Title: Dr. Alan Breier
• Organization: Indiana University

abreier@iupui.edu

317-880-8495

Study Officials

• Alan Breier, MD

  Indiana University

  PRINCIPAL INVESTIGATOR

• Michael Francis, MD

  Indiana University

  PRINCIPAL INVESTIGATOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Psychiatrist

Study Record Dates

• First Submitted: January 11, 2013
• First Posted: January 30, 2013
• Study Start: January 1, 2013
• Primary Completion: August 1, 2016
• Study Completion: August 1, 2016
• Last Updated: April 16, 2019
• Results First Posted: April 16, 2019

Record last verified: 2019-03

Locations

US (3)