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. Author manuscript; available in PMC: 2014 Sep 15.
Published in final edited form as: Cochrane Database Syst Rev. 2011 Jun 15;(6):CD004718. doi: 10.1002/14651858.CD004718.pub3
Methods Allocation: randomised, no further details.
Blinding: open label.
Setting: Germany, outpatient clinic.
Follow-up: two years.
Evaluation: not blinded.
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.
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
Outcomes Leaving the study early.
Mental state: PANSS.
Global state: GAF.
Adverse events.
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