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Table 2 Timing of assessments of endpoints for safety and efficacy

From: Cognitive behavioural therapy versus supportive therapy for persistent positive symptoms in psychotic disorders: The POSITIVE Study, a multicenter, prospective, single-blind, randomised controlled clinical trial

 

T0

T1,2

T3

T4,5

T6

T7,8

T9

F1

F2

F3

F4

 

pre

treatment phase

(monthly assessments)

post

follow-up

(every 6 months)

Month

0

1,2

3

4,5

6

7,8

9

15

21

27

33

Inclusion Assessment

           

Structured Clinical Interview for DSM-IV

x

          

Anamnestic interview

x

          

Safety

           

Severe Adverse Event asessment1

 

x

x

x

x

x

x

x

x

x

x

CDSS [27]

x

x

x

x

x

x

x

x

x

x

x

Clincal Global Impression (CGI)

 

x

x

x

x

x

x

x

x

x

x

Efficacy

           

PANSS [22]

x

x

x

x

x

x

x

x

x

x

x

PSYRATS [28]

x

x

x

x

x

x

x

x

x

x

x

GAF and Social Status

x

x

x

x

x

x

x

x

x

x

x

Blindness Protocol

x

x

x

x

x

x

x

x

x

x

x

CSSRI3 [61]

x

 

x

 

x

 

x

x

x

x

x

EQ-5D [64]

x

 

x

 

x

 

x

x

x

x

x

SUMD [30]

x

     

x

 

x

 

x

AMDP-psychosis items2 [29]

x

     

x

 

x

 

x

Side effect rating scale [65]

x

     

x

 

x

  

SCL-90-R [31]

x

     

x

 

x

 

x

FSKN [33]

x

     

x

 

x

 

x

Neuropsychological test battery

x

     

x

    
  1. 1Suicide, Suicide attempts, 2 items 33-58, 3includes assessment of medication and medication compliance; CDSS: Calgary Depression Scale for Schizophrenia; PANSS: Positive and Negative Syndrome Scale; PSYRATS: Psychotic Symptom Rating Scales; GAF: Global Assessment of Functioning; CSSRI: Client Sociodemographic and Service Receipt Inventory; EQ-5D: Euro Quality of Life - 5 Dimensions; SUMD: Scale to Assess Unawareness of Mental Disorder; SCL: Symptom Check List; FSKN: Frankfurter Selbstkonzeptskalen (Frankfurt Self-Concept Scales)
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ISSN: 1745-6215