Trial · NCT01779700

Fingolimod in Schizophrenia Patients

NCT01779700, Phase 2, Completed, Indiana University; results first posted 2019-04-16

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Fingolimod in Schizophrenia Patients. Trials, record NCT01779700. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01779700

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Fingolimod in Schizophrenia Patients
NCT number: NCT01779700
Status: Completed
Phases: Phase 2
Enrollment: 40 participants, actual
Lead sponsor: Indiana University
Conditions: Schizophrenia
Interventions: Fingolimod, placebo
First posted: 2013-01-30
Last updated: 2019-04-16
Results first posted: 2019-04-16

Source ClinicalTrials.gov

Registered outcomes17

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	QTcB Change	Screening, Day 0, Day 7, Day 14, Day 21, Day 28, Day 35, Day 42, Day 49, Day 56, Day 84, Day 112	To determine the safety of fingolimod, as measured by the electrocardiogram (ECG) QT interval corrected by Bazett's (QTcB) value.
Primary	Levels of Lymphocyte	Baseline, 4 weeks, 8 weeks	To determine the safety of fingolimod, as measured by the absolute lymphocyte count
Primary	Symptom Changes - PANSS Total Score	Baseline, 4 weeks, 8 weeks	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.
Secondary	Verbal Memory - BACS	Baseline, 4 weeks, 8 weeks	The Brief Assessment of Cognition in Schizophrenia (BACS) is a battery specifically designed to measure treatment-related changes in cognition. The BACS utilizes 6 tasks, and has alternate forms, thus minimizing practice effects. Each task generates a raw score (with a higher score indicating better performance): verbal memory 0-75; digit sequencing 0-28; token motor task 0-100; semantic\&letter fluency 0-148; symbol coding 0-110; and tower of London 0-22. The raw scores are used to generate a composite score that is calculated by summing t-scores derived by comparisons with a normative sample of 404 healthy controls. The six brief assessments' t-scores, are summed, and averaged to provide a composite t-score. The composite score min and max are between -43 and 100. A higher score indicating better cognitive performance.
Secondary	Cognition Change - BACS	Baseline, 4 weeks, 8 weeks	The Brief Assessment of Cognition in Schizophrenia (BACS) is a battery specifically designed to measure treatment-related changes in cognition by utilizing 6 tasks, and has alternate forms, thus minimizing practice effects. Each task generates a raw score (with a higher score indicating better performance): verbal memory 0-75; digit sequencing 0-28; token motor task 0-100; semantic\&letter fluency 0-148; symbol coding 0-110; and tower of London 0-22. The raw scores are used to generate a composite score that is calculated by summing t-scores derived by comparisons with a normative sample of 404 healthy controls. The six brief assessments' t-scores, are summed, and averaged to provide a composite t-score. The composite score min and max are between -43 and 100. A higher score indicating better cognitive performance.
Secondary	Cognition Change - Trails B	Baseline, 4 weeks, 8 weeks	The Trail Making Test-Part B (Trails B) is a measure of visual attention and task switching. The task requires a subject to 'connect-the-dots' of 25 consecutive targets on a sheet of paper. In Part B version the subject alternates between numbers and letters (1, A, 2, B, etc.) The goal of the test is for the subject is to finish part B as quickly as possible, the time taken to complete the test is used as the primary performance metric. The score is the number of seconds it took to complete the test.
Secondary	Positive Symptom Change - PANSS	Baseline, 4 weeks, 8 weeks	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.
Secondary	Negative Symptom Change - PANSS	Baseline, 4 weeks, 8 weeks	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.
Secondary	Plasma Cytokines Levels - IL-10	Baseline, 4 weeks, 8 weeks	To assess IL-10 plasma cytokines levels changes in participants taking fingolimod versus placebo
Secondary	Plasma Cytokines Levels - IL-17A	Baseline, 4 weeks, 8 weeks	To assess IL-17A plasma cytokines levels changes in participants taking fingolimod versus placebo

1 to 10 of 17Source ClinicalTrials.gov

See all 17 registered outcomes

Outcomes17

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Units	Measured as
PRIMARY	QTcB Change	Screening, Day 0, Day 7, Day 14, Day 21, Day 28, Day 35, Day 42, Day 49, Day 56, Day 84, Day 112	ms	MEAN
PRIMARY	Levels of Lymphocyte	Baseline, 4 weeks, 8 weeks	10^3 lymphocytes/uL	MEAN
PRIMARY	Symptom Changes - PANSS Total Score	Baseline, 4 weeks, 8 weeks	score on a scale	MEAN
SECONDARY	Verbal Memory - BACS	Baseline, 4 weeks, 8 weeks	score on a scale	MEAN
SECONDARY	Cognition Change - BACS	Baseline, 4 weeks, 8 weeks	score on a scale	MEAN
SECONDARY	Cognition Change - Trails B	Baseline, 4 weeks, 8 weeks	seconds	MEAN
SECONDARY	Positive Symptom Change - PANSS	Baseline, 4 weeks, 8 weeks	score on a scale	MEAN
SECONDARY	Negative Symptom Change - PANSS	Baseline, 4 weeks, 8 weeks	score on a scale	MEAN
SECONDARY	Plasma Cytokines Levels - IL-10	Baseline, 4 weeks, 8 weeks	pg/ml	MEAN
SECONDARY	Plasma Cytokines Levels - IL-17A	Baseline, 4 weeks, 8 weeks	pg/ml	MEAN

1 to 10 of 17Source ClinicalTrials.gov

See all 17 outcomes

Results by group120

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Spread	Units
QTcB Change	Fingolimod	QTcB - Screening	416.50	Standard Deviation 19.24	ms
QTcB Change	Placebo	QTcB - Screening	416.41	Standard Deviation 17.69	ms
QTcB Change	Fingolimod	QTcB - Day 0	418.39	Standard Deviation 23.47	ms
QTcB Change	Placebo	QTcB - Day 0	423.27	Standard Deviation 22.05	ms
QTcB Change	Fingolimod	QTcB - Day 7	415.50	Standard Deviation 16.71	ms
QTcB Change	Placebo	QTcB - Day 7	417.00	Standard Deviation 19.99	ms
QTcB Change	Fingolimod	QTcB - Day 14	418.28	Standard Deviation 16.30	ms
QTcB Change	Placebo	QTcB - Day 14	420.15	Standard Deviation 16.24	ms
QTcB Change	Fingolimod	QTcB - Day 21	419.67	Standard Deviation 18.90	ms
QTcB Change	Placebo	QTcB - Day 21	412.00	Standard Deviation 19.25	ms

1 to 10 of 120Source ClinicalTrials.gov

See all 120 results by group

Participant flow6

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Fingolimod	18
Overall Study	STARTED	Placebo	22
Overall Study	COMPLETED	Fingolimod	14
Overall Study	COMPLETED	Placebo	17
Overall Study	NOT COMPLETED	Fingolimod	4
Overall Study	NOT COMPLETED	Placebo	5

Source ClinicalTrials.gov

Adverse events54

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
other	Asymptomatic Bradycardia	Cardiac disorders	Fingolimod	3	18	3
other	Asymptomatic Bradycardia	Cardiac disorders	Placebo	3	22	4
other	Hyponatremia	Blood and lymphatic system disorders	Fingolimod	0	18	0
other	Hyponatremia	Blood and lymphatic system disorders	Placebo	3	22	3
other	diarrhea	Gastrointestinal disorders	Fingolimod	3	18	3
other	diarrhea	Gastrointestinal disorders	Placebo	2	22	2
other	headache	General disorders	Fingolimod	3	18	3
other	headache	General disorders	Placebo	2	22	2
other	Low back pain	Musculoskeletal and connective tissue disorders	Fingolimod	1	18	1
other	Low back pain	Musculoskeletal and connective tissue disorders	Placebo	1	22	2

1 to 10 of 54Source ClinicalTrials.gov

See all 54 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Fingolimod	0	18
Total, all-cause mortality	Placebo	0	22
Total, other adverse events	Fingolimod	18	18
Total, other adverse events	Placebo	13	22
Total, serious adverse events	Fingolimod	0	18
Total, serious adverse events	Placebo	2	22

Source ClinicalTrials.gov

Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons2

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison	Source
Fingolimod vs Placebo: deaths from any cause	Trial comparisons
Fingolimod vs Placebo: serious adverse events	Trial comparisons

Tests4

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

Test	Named as	Source
Task Switching Test	Secondary outcome	ConductCognition
Tower Planning	Secondary outcome	ConductCognition
Trail Making Test B	Secondary outcome	ConductCognition
Verbal Fluency	Secondary outcome	ConductCognition

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT01779700

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API reference For AI assistants