Assertive community treatment as part of integrated care versus standard care: a 12-month trial in patients with first- and multiple-episode schizophrenia spectrum disorders treated with quetiapine immediate release (ACCESS trial).

OBJECTIVE: The ACCESS trial examined the 12-month effectiveness of continuous therapeutic assertive community treatment (ACT) as part of integrated care compared to standard care in a catchment area comparison design in patients with schizophrenia spectrum disorders treated with quetiapine immediate release. METHOD: Two catchment areas in Hamburg, Germany, with similar population size and health care structures were assigned to offer 12-month ACT as part of integrated care (n = 64) or standard care (n = 56) to 120 patients with first- or multiple-episode schizophrenia spectrum disorders (Structured Clinical Interview for DSM-IV Axis I Disorders criteria); multiple-episode patients were restricted to those with a history of relapse due to medication nonadherence. The primary outcome was time to service disengagement. Secondary outcomes comprised medication nonadherence, improvements of symptoms, functioning, quality of life, satisfaction with care from patients' and relatives' perspectives, and service use data. The study was conducted from April 2005 to December 2008. RESULTS: 17 of 120 patients (14.2%) disengaged with service, 4 patients (6.3%) in the ACT and 13 patients (23.2%) in the standard care group. The mean Kaplan-Meier estimated time in service was 50.7 weeks in the ACT group (95% CI, 49.1-52.0) and 44.1 weeks in the standard care group (95% CI, 40.1-48.1). This difference was statistically significant (P = .0035). Mixed models repeated measures indicated larger improvements for ACT compared to standard care regarding symptoms (P < . 01), illness severity (P < . 001), global functioning (P < . 05), quality of life (P < . 05), and client satisfaction as perceived by patients and family (both P < . 05). Logistic regression analyses revealed that ACT was associated with a higher likelihood of being employed/occupied (P = .001), of living independently (P = .007), and of being adherent with medication (P < . 001) and a lower likelihood of persistent substance misuse (P = .027). CONCLUSIONS: Compared to standard care, intensive therapeutic ACT as part of integrated care could improve 1-year outcome. Future studies need to address in which settings these improvements can be sustained. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT01081418.

Estrogen as an adjuvant therapy to antipsychotics does not prevent relapse in women suffering from schizophrenia: results of a placebo-controlled double-blind study.

The expected therapeutic effect of estrogen as an adjunct treatment to antipsychotics in women suffering from schizophrenia for relapse prevention was to be tested under real-life conditions. A multicenter, randomized, placebo-controlled, double-blind, cross-over study based on an A-B-A-B (and/or B-A-B-A) design was applied. Forty-six hypoestrogenic women with schizophrenia hospitalized for the first time or repeatedly were included in the study. Their average age was 37.9 and they had been suffering from schizophrenia for 8.4 years. During the drug treatment phases, they received a three-phase estrogen-gestagen combination drug (17beta-estradiol+norethisterone acetate) in addition to an antipsychotic drug. Significant effects of the adjuvant hormone replacement therapy on the estradiol levels could be observed, and high and low levels of estradiol prevailed in the active drug and placebo phases, respectively. We did not find any difference either in defined relapse events or in the psychopathology between estradiol replacement and placebo phases. Neither did the required antipsychotic doses or the tolerance data differ between the two phases. Thus, the results of our study do not confirm the hypothesis that a combined estradiol/antipsychotic therapy is superior to an antipsychotic monotherapy for relapse prevention.