Phase 2
N=40
Fingolimod in Schizophrenia Patients
Schizophrenia
Bottom Line
View on ClinicalTrials.gov: NCT01779700 ↗Enrolled (actual)
40
Serious AEs
5.0%
Results posted
Apr 2019
Primary outcome: Primary: QTcB Change — 416.50; 416.41; 418.39; 423.27 ms
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Fingolimod (Drug); placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Indiana University
- Primary completion
- Aug 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY QTcB Change |
416.50; 416.41; 418.39; 423.27; 415.50; 417.00 | — |
| PRIMARY Levels of Lymphocyte |
1.99; 1.97; 0.44; 1.94; 0.49; 2.00 | — |
| PRIMARY Symptom Changes - PANSS Total Score |
48.89; 56.50; 49.78; 53.60; 49.06; 54.94 | — |
| SECONDARY Verbal Memory - BACS |
30.89; 37.45; 33.50; 35.45; 34.69; 36.11 | — |
| SECONDARY Cognition Change - BACS |
25.17; 30.95; 27.67; 32.10; 31.13; 33.50 | — |
| SECONDARY Cognition Change - Trails B |
108.00; 123.64; 97.88; 100.60; 84.53; 102.33 | — |
| SECONDARY Positive Symptom Change - PANSS |
10.83; 13.64; 11.89; 14.00; 10.06; 13.06 | — |
| SECONDARY Negative Symptom Change - PANSS |
15.00; 16.59; 13.89; 14.80; 15.44; 15.06 | — |
| SECONDARY Plasma Cytokines Levels - IL-10 |
16.11; 11.94; 15.50; 9.23; 16.28; 10.42 | — |
| SECONDARY Plasma Cytokines Levels - IL-17A |
3.09; 3.72; 2.58; 2.43; 2.58; 2.69 | — |
| SECONDARY Plasma Cytokines Levels - IL-1BETA |
0.87; 0.69; 0.81; 0.72; 0.82; 0.74 | — |
| SECONDARY Plasma Cytokines Levels - IL-2 |
1.74; 1.27; 1.96; 1.20; 1.77; 1.20 | — |
| SECONDARY Plasma Cytokines Levels - IL-4 |
30.99; 30.74; 27.40; 31.34; 24.20; 32.16 | — |
| SECONDARY Plasma Cytokines Levels - IL-6 |
2.15; 1.90; 2.22; 1.81; 2.16; 1.96 | — |
| SECONDARY Plasma Cytokines Levels - IL-8 |
4.29; 3.83; 3.81; 3.69; 4.18; 3.69 | — |
| SECONDARY Plasma Cytokines Levels - TNFa |
2.11; 1.76; 2.02; 1.86; 2.00; 1.61 | — |
| SECONDARY Plasma Cytokines Levels - IFNgamma |
5.32; 8.32; 4.61; 4.95; 4.32; 5.62 | — |
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.
Eligibility Criteria
Inclusion
- 18 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 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
Exclusion
- 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 3 × upper limit of normal
- Subjects considered a high risk for suicidal acts - active suicidal ideation OR any suicide attempt in 90 days prior to screening
- Subjects who have participated in a clinical trial with any pharmacological treatment intervention for which they received study-related medication in the 4 weeks prior to screening OR Subjects currently receiving treatment (within 1 dosing interval + 4 weeks) with an investigational depot formulation of an antipsychotic medication
- Subjects who demonstrate overtly aggressive behavior or who are deemed to pose a homicidal risk in the investigator's opinion
Data sourced from ClinicalTrials.gov (NCT01779700). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.