Outcome
Type |
Measure |
Description |
Time frame |
Safety issue |
Primary |
psychosocial functioning |
Primary endpoint is the Mini-ICF-APP (=Mini-International Classification of Functioning for limitations of Activities and Participation in Psychological disorders) as a measure of disorders of capacity as defined by the International Classification of Functioning |
6 months |
|
Primary |
psychosocial functioning |
Primary endpoint is the Mini-ICF-APP (=Mini-International Classification of Functioning for limitations of Activities and Participation in Psychological disorders) as a measure of disorders of capacity as defined by the International Classification of Functioning |
12 months |
|
Primary |
psychosocial functioning |
Primary endpoint is the Mini-ICF-APP (=Mini-International Classification of Functioning for limitations of Activities and Participation in Psychological disorders) as a measure of disorders of capacity as defined by the International Classification of Functioning |
24 months |
|
Primary |
psychosocial functioning |
Primary endpoint is the Mini-ICF-APP (=Mini-International Classification of Functioning for limitations of Activities and Participation in Psychological disorders) |
36 months |
|
Secondary |
psychotic symptom severity |
psychotic symptoms measured by Positive and Negative Syndrome Scale (PANSS) |
6 months |
|
Secondary |
psychotic symptom severity |
psychotic symptoms measured by Positive and Negative Syndrome Scale (PANSS) |
12 months |
|
Secondary |
psychotic symptom severity |
psychotic symptoms measured by Positive and Negative Syndrome Scale (PANSS) |
24 months |
|
Secondary |
psychotic symptom severity |
psychotic symptoms measured by Positive and Negative Syndrome Scale (PANSS) |
36 months |
|
Secondary |
depressive symptom severity |
depressive symptoms measured by Calgary Depression Scale for Schizophrenia |
6 months |
|
Secondary |
depressive symptom severity |
depressive symptoms measured by Calgary Depression Scale for Schizophrenia |
12 months |
|
Secondary |
depressive symptom severity |
depressive symptoms measured by Calgary Depression Scale for Schizophrenia |
24 months |
|
Secondary |
depressive symptom severity |
depressive symptoms measured by Calgary Depression Scale for Schizophrenia |
36 months |
|
Secondary |
necessity of hospital treatment |
necessity of hospital (inpatient) treatment, measured cumulative days in hospital per year |
6 months |
|
Secondary |
necessity of hospital treatment |
necessity of hospital (inpatient) treatment, measured cumulative days in hospital per year |
12 months |
|
Secondary |
necessity of hospital treatment |
necessity of hospital (inpatient) treatment, measured cumulative days in hospital per year |
24 months |
|
Secondary |
necessity of hospital treatment |
necessity of hospital (inpatient) treatment, measured cumulative days in hospital per year |
36 months |
|
Secondary |
general symptom severity |
Clinical Global Impression (CGI Severity und Improvement) |
6 months |
|
Secondary |
general symptom severity |
Clinical Global Impression (CGI Severity und Improvement) |
12 months |
|
Secondary |
general symptom severity |
Clinical Global Impression (CGI Severity und Improvement) |
24 months |
|
Secondary |
general symptom severity |
Clinical Global Impression (CGI Severity und Improvement) |
36 months |
|
Secondary |
psychic "structure" |
Axes II-VI (relationships, conflicts, structure) of the Operationalized Psychodynamic Diagnostics (OPD) |
6 months |
|
Secondary |
psychic "structure" |
Axes II-VI (relationships, conflicts, structure) of the Operationalized Psychodynamic Diagnostics (OPD) |
12 months |
|
Secondary |
psychic "structure" |
Axes II-VI (relationships, conflicts, structure) of the Operationalized Psychodynamic Diagnostics (OPD) |
24 months |
|
Secondary |
psychic "structure" |
Axes II-VI (relationships, conflicts, structure) of the Operationalized Psychodynamic Diagnostics (OPD) |
36 months |
|
Secondary |
metacognitive function |
Metacognition Assessment Scale-Abbreviated (MAS-A) |
6 months |
|
Secondary |
metacognitive function |
Metacognition Assessment Scale-Abbreviated (MAS-A) |
12 months |
|
Secondary |
metacognitive function |
Metacognition Assessment Scale-Abbreviated (MAS-A) |
24 months |
|
Secondary |
metacognitive function |
Metacognition Assessment Scale-Abbreviated (MAS-A) |
36 months |
|
Secondary |
cognitive and emotional mentalization |
Movie for the Assessment of Social Cognition (MASC) |
baseline |
|
Secondary |
cognitive and emotional mentalization |
Movie for the Assessment of Social Cognition (MASC) |
12 months |
|
Secondary |
"mentalized affectivity" and emotional awareness |
Levels of Emotional Awareness Scale (LEAS) |
6 months |
|
Secondary |
"mentalized affectivity" and emotional awareness |
Levels of Emotional Awareness Scale (LEAS) |
12 months |
|
Secondary |
"mentalized affectivity" and emotional awareness |
Levels of Emotional Awareness Scale (LEAS) |
24 months |
|
Secondary |
self-rated ability to solve interpersonal problems |
Inventory of Interpersonal Problems (IIP-D) |
6 months |
|
Secondary |
self-rated ability to solve interpersonal problems |
Inventory of Interpersonal Problems (IIP-D) |
12 months |
|
Secondary |
self-rated ability to solve interpersonal problems |
Inventory of Interpersonal Problems (IIP-D) |
24 months |
|
Secondary |
self-rated ability to solve interpersonal problems |
Inventory of Interpersonal Problems (IIP-D) |
36 months |
|
Secondary |
ability to make subjective sense of psychotic experiences |
Questionnaire to assess subjective meaning in psychosis (SuSi) |
6 months |
|
Secondary |
ability to make subjective sense of psychotic experiences |
Questionnaire to assess subjective meaning in psychosis (SuSi) |
12 months |
|
Secondary |
ability to make subjective sense of psychotic experiences |
Questionnaire to assess subjective meaning in psychosis (SuSi) |
24 months |
|
Secondary |
ability to make subjective sense of psychotic experiences |
Questionnaire to assess subjective meaning in psychosis (SuSi) |
36 months |
|
Secondary |
Changes in cerebral functional activity, connectivity, structure of social cognitive and default-mode networks from Baseline |
BOLD-contrast, structure |
baseline |
|
Secondary |
Changes in cerebral functional activity, connectivity, structure of social cognitive and default-mode networks from Baseline |
BOLD-contrast, structure |
24 months |
|