Trial Outcomes & Findings for Biomarkers in First Episode Schizophrenia (NCT NCT02033382)
NCT ID: NCT02033382
Last Updated: 2021-01-14
Results Overview
Compare biomarkers for inflammation, BDNF, oxidative stress, glucocorticoids and folate/methylation status in medication-naïve schizophrenia/schizophreniform subjects and matched healthy controls to identify illness-related factors.
COMPLETED
165 participants
Baseline
2021-01-14
Participant Flow
Participant milestones
| Measure |
Healthy Controls
Age and gender matched healthy controls
|
Patients
Participants diagnosed with Schizophrenia, schizophreniform disorder, or schizoaffective disorder, depressed type that are naive to anti-psychotic treatment.
|
|---|---|---|
|
Overall Study
STARTED
|
83
|
82
|
|
Overall Study
COMPLETED
|
32
|
36
|
|
Overall Study
NOT COMPLETED
|
51
|
46
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Biomarkers in First Episode Schizophrenia
Baseline characteristics by cohort
| Measure |
Healthy Controls
n=73 Participants
Age and gender matched healthy controls
|
Patients
n=79 Participants
Participants diagnosed with Schizophrenia, schizophreniform disorder, or schizoaffective disorder, depressed type that are naive to anti-psychotic treatment.
|
Total
n=152 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
23.86 years
STANDARD_DEVIATION 6.40 • n=39 Participants
|
25.19 years
STANDARD_DEVIATION 7.39 • n=41 Participants
|
24.56 years
STANDARD_DEVIATION 6.95 • n=35 Participants
|
|
Sex: Female, Male
Female
|
40 Participants
n=39 Participants
|
40 Participants
n=41 Participants
|
80 Participants
n=35 Participants
|
|
Sex: Female, Male
Male
|
33 Participants
n=39 Participants
|
39 Participants
n=41 Participants
|
72 Participants
n=35 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Race (NIH/OMB)
Asian
|
73 Participants
n=39 Participants
|
74 Participants
n=41 Participants
|
147 Participants
n=35 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=39 Participants
|
3 Participants
n=41 Participants
|
3 Participants
n=35 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=39 Participants
|
2 Participants
n=41 Participants
|
2 Participants
n=35 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Region of Enrollment
China
|
73 participants
n=39 Participants
|
79 participants
n=41 Participants
|
152 participants
n=35 Participants
|
PRIMARY outcome
Timeframe: BaselinePopulation: Not all biomarkers were available for analysis for all subjects.
Compare biomarkers for inflammation, BDNF, oxidative stress, glucocorticoids and folate/methylation status in medication-naïve schizophrenia/schizophreniform subjects and matched healthy controls to identify illness-related factors.
Outcome measures
| Measure |
Healthy Controls
n=62 Participants
Age and gender matched healthy controls
|
Patients
n=69 Participants
Participants diagnosed with Schizophrenia, schizophreniform disorder, or schizoaffective disorder, depressed type that are naive to anti-psychotic treatment.
|
|---|---|---|
|
Biomarkers
Interleukin 1B
|
76.77 pg/mL
Interval 44.41 to 225.11
|
68.82 pg/mL
Interval 35.35 to 166.58
|
|
Biomarkers
Interleukin 8
|
63.41 pg/mL
Interval 50.77 to 82.46
|
71.30 pg/mL
Interval 49.79 to 83.26
|
|
Biomarkers
Tumor Necrosis Factor
|
92.03 pg/mL
Interval 74.28 to 103.94
|
93.60 pg/mL
Interval 76.02 to 105.44
|
|
Biomarkers
Interferon gamma
|
88.96 pg/mL
Interval 64.69 to 131.47
|
89.42 pg/mL
Interval 70.87 to 113.86
|
|
Biomarkers
Aspartate
|
102.32 pg/mL
Interval 79.33 to 141.65
|
134.32 pg/mL
Interval 86.67 to 198.31
|
|
Biomarkers
Lactate
|
13.28 pg/mL
Interval 9.83 to 17.75
|
15.08 pg/mL
Interval 11.27 to 20.34
|
|
Biomarkers
BDNF
|
287.37 pg/mL
Interval 145.99 to 722.44
|
340.83 pg/mL
Interval 142.52 to 340.83
|
|
Biomarkers
Thioredoxin
|
492.33 pg/mL
Interval 324.17 to 637.67
|
420.17 pg/mL
Interval 323.58 to 609.5
|
|
Biomarkers
S100B
|
130.44 pg/mL
Interval 61.14 to 265.52
|
125.13 pg/mL
Interval 69.76 to 211.93
|
|
Biomarkers
C-Reactive Protein
|
7610.07 pg/mL
Interval 6937.9 to 9025.92
|
7631.41 pg/mL
Interval 6778.62 to 9456.46
|
|
Biomarkers
Glutamate
|
105.00 pg/mL
Interval 92.0 to 121.6
|
111.00 pg/mL
Interval 98.2 to 128.0
|
|
Biomarkers
Homocysteine
|
4.79 pg/mL
Interval 4.44 to 5.38
|
4.83 pg/mL
Interval 4.53 to 5.26
|
PRIMARY outcome
Timeframe: Baseline and week 8Population: Analysis was done for first episode participants who completed both Baseline and Week 8 only.
Compare biomarkers at baseline and after 8 weeks of risperidone treatment in medication-naïve schizophrenia/schizophreniform subjects to identify treatment-related factors. Since Blood and Saliva was only collected from First Episode participants (FEP) at week 8 (not from healthy controls) these results only report the baseline and week 8 biomarker levels for FEP participants who completed week 8.
Outcome measures
| Measure |
Healthy Controls
n=29 Participants
Age and gender matched healthy controls
|
Patients
n=29 Participants
Participants diagnosed with Schizophrenia, schizophreniform disorder, or schizoaffective disorder, depressed type that are naive to anti-psychotic treatment.
|
|---|---|---|
|
Salivary Cortisol Levels
C-reactive protein
|
7541.41 pg/mL
Interval 6647.32 to 9445.12
|
7627.60 pg/mL
Interval 6708.99 to 9474.72
|
|
Salivary Cortisol Levels
Interleukin 1B
|
68.81 pg/mL
Interval 34.82 to 153.33
|
57.01 pg/mL
Interval 28.18 to 168.11
|
|
Salivary Cortisol Levels
Interleukin 8
|
74.34 pg/mL
Interval 50.02 to 93.98
|
65.79 pg/mL
Interval 51.16 to 82.38
|
|
Salivary Cortisol Levels
Interferon gamma
|
95.26 pg/mL
Interval 73.44 to 117.9
|
98.14 pg/mL
Interval 61.71 to 124.71
|
|
Salivary Cortisol Levels
Tumor necrosis factor
|
93.60 pg/mL
Interval 75.75 to 107.69
|
89.45 pg/mL
Interval 71.25 to 109.15
|
|
Salivary Cortisol Levels
Aspartate
|
3.71 pg/mL
Interval 2.6 to 4.55
|
4.75 pg/mL
Interval 3.76 to 6.37
|
|
Salivary Cortisol Levels
Glutamate
|
5.21 pg/mL
Interval 4.54 to 6.2
|
5.29 pg/mL
Interval 4.77 to 6.33
|
|
Salivary Cortisol Levels
Lactate
|
4.49 pg/mL
Interval 3.11 to 5.21
|
3.95 pg/mL
Interval 2.75 to 6.11
|
|
Salivary Cortisol Levels
Homocysteine
|
4.78 pg/mL
Interval 4.51 to 5.11
|
5.02 pg/mL
Interval 4.75 to 5.31
|
|
Salivary Cortisol Levels
BDNF
|
465.98 pg/mL
Interval 145.23 to 1965.72
|
356.20 pg/mL
Interval 218.79 to 1040.88
|
|
Salivary Cortisol Levels
Thioredoxin
|
417.50 pg/mL
Interval 291.67 to 547.75
|
405.33 pg/mL
Interval 326.92 to 519.25
|
|
Salivary Cortisol Levels
S100B
|
154.63 pg/mL
Interval 91.25 to 299.88
|
111.39 pg/mL
Interval 49.78 to 278.73
|
PRIMARY outcome
Timeframe: BaselineCompare biomarkers for stress (salivary cortisol) in medication-naïve schizophrenia/schizophreniform subjects and matched healthy controls to identify illness-related factors.
Outcome measures
| Measure |
Healthy Controls
n=54 Participants
Age and gender matched healthy controls
|
Patients
n=46 Participants
Participants diagnosed with Schizophrenia, schizophreniform disorder, or schizoaffective disorder, depressed type that are naive to anti-psychotic treatment.
|
|---|---|---|
|
Salivary Cortisol Levels
|
4.88 µg/dL
Interval 3.19 to 7.51
|
6.56 µg/dL
Interval 4.18 to 8.98
|
PRIMARY outcome
Timeframe: Baseline and week 8Population: Analysis was done for first episode subjects who completed both Baseline and Week 8 only.
Compare salivary cortisol at baseline and after 8 weeks of risperidone treatment in medication-naïve schizophrenia/schizophreniform subjects to identify treatment-related factors. Since Blood and Saliva was only collected from First Episode participants (FEP) at week 8 (not from healthy controls) these results only report the baseline and week 8 biomarker levels for FEP participants who completed week 8.
Outcome measures
| Measure |
Healthy Controls
n=19 Participants
Age and gender matched healthy controls
|
Patients
n=19 Participants
Participants diagnosed with Schizophrenia, schizophreniform disorder, or schizoaffective disorder, depressed type that are naive to anti-psychotic treatment.
|
|---|---|---|
|
Change in Salivary Cortisol Levels
|
7.41 µg/dL
Interval 1.89 to 9.17
|
4.36 µg/dL
Interval 2.37 to 8.2
|
SECONDARY outcome
Timeframe: BaselineCompare hippocampal volume in medication-naïve schizophrenia/schizophreniform subjects and healthy controls and examine whether biomarkers predict differences between groups in baseline hippocampal volume.
Outcome measures
| Measure |
Healthy Controls
n=54 Participants
Age and gender matched healthy controls
|
Patients
n=57 Participants
Participants diagnosed with Schizophrenia, schizophreniform disorder, or schizoaffective disorder, depressed type that are naive to anti-psychotic treatment.
|
|---|---|---|
|
Left Hippocampal Volumetric Integrity (HVI)
|
.9512 % of hippocampal volumetric integrity
Interval 0.8501 to 0.9825
|
.9275 % of hippocampal volumetric integrity
Interval 0.8256 to 0.9689
|
SECONDARY outcome
Timeframe: Baseline, week 8Population: Data provided only for subjects who completed assessments at both time points.
Compare cognitive performance on the Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery (MCCB) in medication- naïve schizophrenia/schizophreniform subjects and healthy controls and examine whether biomarkers predict differences between groups in baseline cognitive performance. The composite score on the MCCB is calculated by the software using all tests administered. The composite score is a t-score assuming the mean score (50%) is the normative performance of the general population. The composite score ranges from 0-100 with a standard deviation of 10. A score greater than 50 implies a score better than the average population norm and a score less than 50 indicates performance worse than the general population norm. For schizophrenia subjects who complete 8 weeks of antipsychotic treatment, week 8 MATRICS testing results will be used to minimize the effect of psychosis on cognitive performance.
Outcome measures
| Measure |
Healthy Controls
n=36 Participants
Age and gender matched healthy controls
|
Patients
n=30 Participants
Participants diagnosed with Schizophrenia, schizophreniform disorder, or schizoaffective disorder, depressed type that are naive to anti-psychotic treatment.
|
|---|---|---|
|
Cognitive Performance
Baseline MCCB Composite Score
|
47.50 units on a scale
Interval 41.0 to 53.0
|
34 units on a scale
Interval 24.5 to 45.25
|
|
Cognitive Performance
Week 8 MCCB Composite Score
|
49.50 units on a scale
Interval 44.25 to 54.0
|
42.50 units on a scale
Interval 32.25 to 49.0
|
SECONDARY outcome
Timeframe: Baseline, week 8Population: This analysis includes participants that completed both baseline and week 8 visits.
Compare hippocampal volume in medication-naïve schizophrenia/schizophreniform subjects before and after 8 weeks treatment with antipsychotic to assess evidence for early neurotoxicity. This outcome measure reports annualized rate of change in Left Hippocampal Volume Integrity (LHVI) because a few participants had a delay in their week 8 visit.
Outcome measures
| Measure |
Healthy Controls
n=31 Participants
Age and gender matched healthy controls
|
Patients
n=24 Participants
Participants diagnosed with Schizophrenia, schizophreniform disorder, or schizoaffective disorder, depressed type that are naive to anti-psychotic treatment.
|
|---|---|---|
|
Annualized Change in Left Hippocampal Volume Integrity
|
0.004535 Percentage of standard hippocampal vol.
Interval -0.0151 to 0.035
|
-0.03027 Percentage of standard hippocampal vol.
Interval -0.0817 to 0.00004
|
Adverse Events
Healthy Controls
Patients
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Healthy Controls
n=73 participants at risk
Age and gender matched healthy controls
|
Patients
n=79 participants at risk
Participants diagnosed with Schizophrenia, schizophreniform disorder, or schizoaffective disorder, depressed type that are naive to anti-psychotic treatment.
|
|---|---|---|
|
Eye disorders
Blurred Vision
|
0.00%
0/73
|
1.3%
1/79 • Number of events 1
|
|
Cardiac disorders
Hypertension
|
0.00%
0/73
|
1.3%
1/79 • Number of events 1
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place