BACKGROUND Non-adherence with antipsychotic medication is common in patients with schizophrenia. AIMS To establish the efficacy of adherence therapy (AT) compared to treatment as usual (TAU) in improving medication compliance in patients following an acute episode of schizophrenia. METHOD The study was designed as a parallel group, single blind, randomised controlled trial. Fieldwork was conducted in four centres (3 in Germany and 1 in Switzerland) and involved a total of 161 patients. Patients received 8 sessions of AT in addition to treatment as usual. The main outcomes of this study were adherence and psychopathology at 12 weeks post discharge follow up. RESULTS In total 80 patients received AT and 57 TAU. Intention-to-treat analysis included all randomised patients. Psychopathology, as determined using the PANSS-total, improved in the AT compared to TAU group by a mean of -6.16 points 12 weeks after discharge from hospital (p<.05). AT had no significant effects on patients' adherence, treatment attitudes or functioning. No significant adverse events were reported. CONCLUSION AT improves psychopathology in patients recovering from an acute episode of schizophrenia.