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Table 1 Tabulated results extracted from 18 eligible studies in the ClinicalTrials.gov database from January 2004 through September 2015

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

     
  1. NR not reported, ACSA Amphetamine Cessation Symptom Assessment, BACS Brief Assessment of Cognition in Schizophrenia, BAS Barnes Akathisia Scale, BOLD blood oxygenation-level dependant, BRIEF-A behavioural rating inventory of executive function—adult version, CDSS Calgary Depression Scale for Schizophrenia, CGAS Children’s Global Assessment Scale, CGI-I Clinical Global Improvement Impression Scale, CGI-S Clinical Global Impression Severity Scale, CPT Continuous Performance Task, ESS Epworth Sleepiness Scale, GAS Global Assessment of Functioning Scale, HQoL Heinrich Quality of Life Scale, HVLT Hopkins Verbal Learning Test, HVLT-R Hopkins Verbal Learning Test—Revised, HKLLT Hong Kong List Learning Task, LNS Letter-Number Span Test, MATRICS Measurement and Treatment Research to Improve Cognition in Schizophrenia, MCCB MATRICS Consensus Cognition Battery, PANSS Positive and Negative Syndrome Scale, PGIC Patient Global Impression of Change, PSQI Pittsburgh Sleep Quality Index, QLS Quality of Life Scale, SANS Scale for the Assessment of Negative Symptoms, SAS Simpson Angus Scale, SCoRS Schizophrenia Cognition Rating Scale, UPSA-B University of California Performance-Based Skills Assessment, Brief Version, WCST Wisconsin Card Sorting Test