From: Realising stratified psychiatry using multidimensional signatures and trajectories
Study (citation) | Dx | Individual symptoms/clusters | Patient specific response Factors | Primary outcome | Measurement type | Measure subject specific | Change considered | Sig. eff. | Secondary outcome | Measurement type | Measure subject specific | Change considered | Sig. eff. | Score |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
NCT00548327 | Scz/SczAff | None | COMT allele | fMRI BOLD signal change in DLPFC | Group (by COMT) difference | Yes—COMT status | Hours | No | Neuropsychological testing | Not specified | Not specified | Days | No | 4 |
Healthy control | Plasma drug level | No | PANSS | Not specified | Not specified | Days | No | |||||||
NCT00560937 | Scz/SczAff | Cognitive testing score threshold | None | SANS | Total score | No | Weeks | Yes | CDSS | Mean score | No | Weeks | No | 2 |
BACS | Mean score | No | Weeks | No | CGI | Total score | No | Weeks | Yes | |||||
MATRICS | Composite score | No | Weeks | No | PANSS | Mean score | No | Weeks | NR | |||||
NCT00611806 [97] | Scz (DSM) | Negative symptoms | COMT allele | PANSS | Total score | Weeks | No | MATRICS | Composite | No | Weeks | NR | 5 | |
Positive symptoms | Plasma levels (of folate, B12, homocysteine) | PANSS | Positive score | Plasma levels/genotype | Weeks | No | ||||||||
PANSS | Total score | Genotype | Weeks | No | ||||||||||
SANS | Total score | Genotype | Weeks | Yes | ||||||||||
NCT00931996 | Scz (DSM) | PANSS score threshold | None | PANSS | Total score | No | Weeks | No | None | 1 | ||||
NCT00963924 (Cain et al. [133]) | Scz/SczAff | Auditory discrimination | SANS score | MATRICS | Composite score | No | Weeks | Yes | MATRICS | Subscores | Yes | Weeks | Yes | 4 |
SANS score | SANS | Total score | Yes | Weeks | Yes | |||||||||
NCT00488319 | Scz (DSM) | None | None | Adverse event rate | Number of events | No | Years | NR | PANSS | 5 factors | No | Years | Yes | 2 |
GAS | Total score | No | Years | NR | ||||||||||
Motor domains | Individual domain scores | No | Weeks | NR | ||||||||||
Memory | Domain scores | No | Weeks | NR | ||||||||||
Verbal | Domain scores | No | Weeks | NR | ||||||||||
Theory of mind | Total score | No | Weeks | NR | ||||||||||
Cognitive | Domain scores | No | Weeks | NR | ||||||||||
Sleep | Domain scores | No | Years | NR | ||||||||||
NCT01312272 (Davis et al.[134]) | Scz (DSM) | None | None | Social cognition | Composite mean score | No | Days | No | Theory of mind | Total score | No | Days | No | 2 |
Empathy | Domain scores | No | Days | Yes | ||||||||||
Social perception | Domain scores | No | Days | No | ||||||||||
Facial affect recog. | Domain scores | No | Days | No | ||||||||||
PANSS | Total score | No | Days | No | ||||||||||
NCT00922272 | Scz (DSM) | Negative symptoms | None | SANS | Total score | No | Weeks | Yes | SANS | Response (total, dichotomised) | No | Weeks | No | 3 |
SANS | Remission (total, dichotomised) | No | Weeks | No | ||||||||||
SANS | Domain scores | No | Weeks | Partial | ||||||||||
PANSS | Domain scores | No | Weeks | Partial | ||||||||||
CGI | Domain scores | No | Weeks | No | ||||||||||
BACS | Total score | No | Weeks | No | ||||||||||
Cognitive | Domain scores | No | Weeks | Partial | ||||||||||
California performance skills | Domain scores | No | Weeks | No | ||||||||||
SAS | Total score | No | Weeks | No | ||||||||||
BAS/BARS | Total score | No | Weeks | No | ||||||||||
Sleep | Domain scores | No | Weeks | No | ||||||||||
CDSS | Total score | No | Weeks | No | ||||||||||
NCT00487942 (Kane et al. [135]) | Scz (DSM) | None | Named SGA (antipsychotic) | MATRICS | Composite score | No | Weeks | No | MATRICS | Domain scores | No | Weeks | No | 3 |
Frontal Tests | Domain scores | No | Weeks | No | ||||||||||
Actigraphy | Mean scores | No | Weeks | No | ||||||||||
SCoRS | Total scores | No | Weeks | No | ||||||||||
SANS | Total scores | No | Weeks | Yes | ||||||||||
PANSS | Total scores | No | Weeks | No | ||||||||||
PANSS | Positive symptoms | No | Weeks | No | ||||||||||
Sleep | Domain scores | No | Weeks | No | ||||||||||
SAS | Total scores | No | Weeks | No | ||||||||||
BAS/BARS | Total scores | No | Weeks | No | ||||||||||
CDSS | Total scores | No | Weeks | No | ||||||||||
NCT01363349 | Scz (DSM) | Delusions score | Stable antipsychotic | MATRICS | Composite score | No | Weeks | No | Long term cognitive state | Not specified | No | Weeks | NR | 2 |
Hallucinations score | Not treatment resistant | |||||||||||||
Conceptual disorganisation | ||||||||||||||
Persecutory thought | ||||||||||||||
NCT00575666 | Scz | None | None | Cognition | Domain scores | No | Weeks | No | None | 2 | ||||
SczAff | (digit span, verbal fluency, recall, frontal, attention, reaction time) | |||||||||||||
PANSS | Total score | No | Weeks | No | ||||||||||
PANSS | Domain scores | No | Weeks | No | ||||||||||
SANS | Total score | No | Weeks | No | ||||||||||
CDSS | Total score | No | Weeks | No | ||||||||||
NCT00848484 | Scz | None | Illness duration <1 year | BACS | Composite score | No | Weeks | No | CogState | Composite score | No | Weeks | No | 2 |
Executive function | Domain score | No | Weeks | No | ||||||||||
Episodic memory | Domain score | No | Weeks | No | ||||||||||
Working memory | Domain score | No | Weeks | No | ||||||||||
Attention | Domain score | No | Weeks | No | ||||||||||
NCT00435370 (Zhang et al. [136]) | Scz/schizophreniform | BPRS “psychotic” features | EEG P50 ratio | MATRICS | Composite score | No | Days | Yes | None | 4 | ||||
RBANS | Total score | Yes | Days | Yes | ||||||||||
RBANS | Domain scores | Yes | Days | Yes | ||||||||||
NCT01082588 | Scz/SczAff | None | None | LDL cholesterol | Group mean | No | Weeks | No | None | 2 | ||||
C-Reactive protein | Group mean | No | Weeks | No | ||||||||||
MATRICS | Composite score | No | Weeks | No | ||||||||||
PANSS | Total score | No | Weeks | No | ||||||||||
PANSS | Domain scores | No | Weeks | No | ||||||||||
NCT00563706 | Scz | Acute exacerbation (not defined) | None | PANSS | Total score | No | Weeks | Partial | PANSS | Domain scores | No | Weeks | NR | 2 |
CGI | Total score | No | Weeks | NR | ||||||||||
CDSS | Total score | No | Weeks | NR | ||||||||||
NCT00506077 (Egan et al. [137]) | Scz | Total PANSS in range 36–75 | Matching Baseline BACS scores | BACS | Composite score | Partial (baseline matched) | Weeks | No | Neuropsychological testing | Domain scores | Partial (baseline matched) | Weeks | No | 4 |
NCT00646581 | Scz/SczAff | None | Stable antipsychotic | Cognition | Domain scores | No | Minutes | No | None | 2 | ||||
(immediate and delayed recall, frontal, sustained attention, reaction time) | ||||||||||||||
NCT00455702 (Goff et al. [138]) | Scz/SczAff | SczAff: Depressed type | Stable antipsychotic | SANS | Total score | Yes (demographics) | Hours/weeks | Yes | PANSS | Domain scores | No | Weeks | No | 4 |
Cognition | Composite score | No | Weeks | No | SANS | Response (dichotomoised) | No | Weeks | No | |||||
(Visual and verbal learning, frontal, working and episodic memory, motor) | CGI | Total score | No | Weeks | No | |||||||||
Cognition | Domain scores | No | Weeks | Partial | ||||||||||
(visual and verbal learning, frontal, working and episodic memory, motor) | ||||||||||||||
NCT00505076 (Buchanan et al. [139]) | Scz | Low BPRS scores for positive symptoms | Treated with SGA | MATRICS | Composite score | No | Weeks | No | UPSA | Summary Total score | No | Weeks | No | 2 |
Low performance on cognition battery | SCoRS | Total score | No | Weeks | No | |||||||||
NCT00000371 (Goff et al. [140]) | Scz (DSM) | Prominent negative symptoms | Stable antipsychotic | SANS | Total score | No | Weeks/months | No | SANS | Domain scores | Yes | Weeks/months | No | 4 |
Serum concentrations of d-cycloserine, glycine, serine, glutamate | PANSS | Yes | Weeks/months | No | ||||||||||
SANS correlation with Serum concentrations | Yes | Weeks/months | No | |||||||||||
NCT00333970 | Scz spectrum disorders | Neuropsych. Baseline | Demographics (not specified) | Verbal memory (CVLT) | Total score | Not reported | Weeks | No | None | 2 | ||||
Illness variables (not specified) | ||||||||||||||
NCT01315002 | Scz (DSM) | None | Smoking status | Antisaccade task performance | Percentage errors on task | No | Hours | Yes | None | 2 | ||||
1st degree relatives | Stable antipsychotic | |||||||||||||
Genetic polymorphisms for cholinergic systems | ||||||||||||||
NCT01207219 | Scz/SczAff (DSM) | None | None | Verbal acquisition (HKLLT) | Total correct | No | Weeks | NR | PANSS | Domain scores | None | Weeks | Not reported | 0 |
Schizophreniform, brief psychotic disorder, delusional disorder | Verbal retention (HKLLT) | Total correct | No | Weeks | NR | |||||||||
Working memory (digit space) | Total correct | No | Weeks | NR | ||||||||||
Working memory (letter cancellation) | Composite score | No | Weeks | NR |