Methods | Allocation: randomised, no further details. Blinding: open label. Setting: Germany, outpatient clinic. Follow-up: two years. Evaluation: not blinded. |
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Participants | Diagnosis: prodromal at risk of psychosis. N=124. Age: mean age 25 years. Sex: M 70, F 54. Inclusion criteria: adapted ERIraos criteria, age range restricted between 18-36 years. Exclusion criteria: any lifetime DSM-IV diagnosis of schizophrenia, bipolar disorder, any DSM-IV diagnosis of brief psychotic episode with a duration of more than 1 week; delirium, dementia, and other cognitive disorders, mental retardation, mental disorders due to a general medical condition or mental disturbances due to psychotropic substances, alcohol abuse or drugs within the past 3 months. History: no details. |
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Interventions | 1. Needs Focused Intervention* with amisulpride mean dose 118 mg/day. N=65. 2. Needs Focused Intervention. N=59. Use of chloral hydrate or short-acting benzodiazepines were allowed to treat agitation or sleep disturbances, and biperiden permitted for EPS. Citalopram permitted for depression |
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Outcomes | Leaving the study early. Mental state: PANSS. Global state: GAF. Adverse events. |
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Notes | *Needs Focused Intervention included psychoeducation, crisis intervention, family counselling and assistance with education or work-related difficulties according to the patient’s need | |
Risk of bias | ||
Bias | Authors’ judgement | Support for judgement |
Adequate sequence generation? | Unclear risk | Randomised, no further details. |
Allocation concealment? | Unclear risk | No details. |
Blinding? All outcomes |
High risk | Open label. |
Incomplete outcome data addressed? All outcomes |
Low risk | Study attrition reported. |
Free of selective reporting? | Unclear risk | No details. |
Free of other bias? | High risk | Funded by German Federal Ministry for Educaton and research BMBF grant and Sanofi Synthelabo, Germany |