Shortened Positive and Negative Symptom Scale as an Alternate Clinical Endpoint for Acute Schizophrenia Trials: Analysis from the US Food & Drug Administration
Abstract
Objective
Design
Results
Conclusions
Methods
Data Collection
Characteristic | Number | % |
---|---|---|
Number of trials | 32 | |
6‐week trials | 28 | 87.5 |
4‐week trials | 4 | 12.5 |
Number of treatment arms (including active control) versus placebo | 86 | |
Total number of subjects | 14,219 | |
Subjects randomized to placebo | 3533 | 24.8 |
Subjects randomized to drug treatment (including active control) | 10,686 | 75.2 |
Demographics | Mean | (SD) or (%) |
---|---|---|
Age, years | 39.0 | 11.0 |
Females | 4414 | 31.0% |
Caucasian | 7183 | 51.5% |
African Americans | 4346 | 30.5% |
Asians + others | 2690 | 18.0% |
Baseline total PANSS | 94.4 | 13.6 |
Derivation of mPANSS
Concordance Analysis
Sample Size Estimation
Results
Derivation of mPANSS
Summary of baseline PANSS item scores
Item response analysis to derive modified PANSS
Item | Criterion 1 | Criterion 2 | Criterion 3 | Criterion 4 | Criterion 5 | Evaluation |
---|---|---|---|---|---|---|
Positive subscale items | ||||||
P1: Delusions | Yes | Yes | Yes | Yes | Yes | Very good |
P2:Conceptual disorganization | Some | No | Some | Yes | No | Poor |
P3: Hallucination | Yes | Some | Yes | Yes | Yes | Good |
P4: Excitement | Some | Some | Yes | Yes | Yes | Good |
P5: Grandiosity | Some | No | Some | Yes | Yes | Poor |
P6: Suspiciousness | Yes | Yes | Yes | Yes | Yes | Very good |
P7: Hostility | Yes | Some | Yes | Yes | Yes | Good |
Negative subscale items | ||||||
N1: Blunted effect | Yes | Yes | Yes | Yes | Yes | Very good |
N2: Emotional withdrawal | Yes | Yes | Yes | Yes | Yes | Very good |
N3: Poor rapport | Yes | Yes | Yes | Yes | Yes | Very good |
N4: Passive social withdrawal | Yes | Yes | Yes | Yes | Yes | Very good |
N5: Difficulty in abstract thinking | Yes | Some | Yes | Yes | Yes | Good |
N6: Lack of spontaneity | Yes | Yes | Yes | Yes | Yes | Very good |
N7: Stereotyped thinking | Some | Some | Some | Yes | Yes | Poor |
General psychopathology subscale items | ||||||
G1: Somatic concern | Some | No | Some | No | No | Poor |
G2: Anxiety | Some | No | Some | No | No | Poor |
G3: Guilt feelings | No | No | No | No | No | Poor |
G4: Tension | Yes | Some | Yes | Yes | Yes | Good |
G5: Mannerisms & posturing | Some | Some | Some | Yes | Yes | Poor |
G6: Depression | Some | No | Some | No | No | Poor |
G7: Motor retardation | Some | Some | Some | Yes | No | Poor |
G8: Uncooperative | Yes | Yes | Yes | Yes | Yes | Very good |
G9: Unusual thought content | Yes | Some | Yes | Yes | Yes | Good |
G10: Disorientation | Some | Some | Some | Yes | Yes | Poor |
G11: Poor attention | Yes | Yes | Yes | Yes | Yes | Very good |
G12: Lack of judgment | Yes | Yes | Yes | Yes | Yes | Very good |
G13: Disturbance volition | Yes | Yes | Yes | Yes | Yes | Very good |
G14: Poor impulse control | Some | Some | Some | Yes | Yes | Poor |
G15: Pre‐occupation | Yes | Yes | Yes | Yes | Yes | Very good |
G16: Social avoidance | Yes | Some | Yes | Yes | Yes | Good |
Concordance Analysis
Concordance rate (6‐week mPANSS vs. 6‐week total PANSS) | |
---|---|
Overall | 97.6% (84/86) [false negative: 1, false positive:1] |
By trial design | |
Fixed | 97.1% |
Flexible | 100% |
By drug | |
1 | 100% |
2 | 100% |
3 | 100% |
4 | 100% |
5 | 100% |
6 | 100% |
7 | 90% [false positive:1] |
8 | 92.3% [false negative: 1] |
Sample Size Considerations
Discussion
Footnotes
Supplementary Material
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