Clinical trial NCT01081418: Assertive Community Treatment (ACT) in Schizophrenia Spectrum Disorders
Official title: Assertive Community Treatment (ACT) as Part of Integrated Care Versus Standard Care: a 12-month Trial in Patients With First- and Negatively Selected Multiple-episode Schizophrenia-spectrum Disorders Treated With Quetiapine IR
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Schizophrenia
Keywords: Schizophrenia, assertive community treatment, quetiapine
Lead sponsor: Universitätsklinikum Hamburg-Eppendorf
Sponsor class: OTHER
First posted: 2010-03-05
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The study examined the 12-month effectiveness of continuous therapeutic assertive community treatment (ACT) as part of integrated care (IC) compared to standard care (SC) in a catchment area comparison design in patients with schizophrenia spectrum disorders (SSD) treated with quetiapine IR.

Detailed description: Two catchment areas in Hamburg, Germany with similar population size and health care structures were assigned to offer 12-month ACT (\& IC; Department of Psychiatry and Psychotherapy, University Medical Center Hamburg-Eppendorf) or SC (Asklepios Hospital, Department of Psychiatry and Psychotherapy) to 120 first-episode and negatively selected multiple-episode patients with SSD. Primary outcome was the time to Service Disengagement. Secondary outcomes comprised medication non-adherence, improvements of symptoms, functioning, quality of life, satisfaction with care from patients and relatives perspectives, and service use data.

Eligibility criteria: Inclusion Criteria:

* Age 18-65 years
* Met the diagnostic criteria of a first- or multiple episode of a schizophrenia spectrum disorders, i.e. schizophrenia, schizophreniform disorder, schizoaffective disorder, delusional disorder, or psychotic disorder NOS
* New initiation or current treatment with quetiapine Immediate Release (IR)

Exclusion Criteria:

* Other psychotic disorders (e.g., due to medical condition)
* Mental retardation (IQ lower than 70 points)

Primary outcomes:
measure: Time to Service Disengagement
timeFrame: 12 months
Secondary outcomes:
measure: Improvements of symptoms, functioning, quality of life, and satisfaction with care from patients and relatives perspectives
timeFrame: 12 months
Other outcomes:
Locations:
city: Hamburg
country: Germany
facility: University Medical Center Hamburg
Study officials:
affiliation: Psychosis Centre, Department of Psychiatry and Psychotherapy, University Medical Center Hamburg
name: Martin Lambert, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Karow A, Brettschneider C, Helmut Konig H, Correll CU, Schottle D, Ludecke D, Rohenkohl A, Ruppelt F, Kraft V, Gallinat J, Lambert M. Better care for less money: cost-effectiveness of integrated care in multi-episode patients with severe psychosis. Acta Psychiatr Scand. 2020 Mar;141(3):221-230. doi: 10.1111/acps.13139. Epub 2020 Jan 12.
citation: Karow A, Reimer J, Konig HH, Heider D, Bock T, Huber C, Schottle D, Meister K, Rietschel L, Ohm G, Schulz H, Naber D, Schimmelmann BG, Lambert M. Cost-effectiveness of 12-month therapeutic assertive community treatment as part of integrated care versus standard care in patients with schizophrenia treated with quetiapine immediate release (ACCESS trial). J Clin Psychiatry. 2012 Mar;73(3):e402-8. doi: 10.4088/JCP.11m06875.
citation: Lambert M, Bock T, Schottle D, Golks D, Meister K, Rietschel L, Bussopulos A, Frieling M, Schodlbauer M, Burlon M, Huber CG, Ohm G, Pakrasi M, Chirazi-Stark MS, Naber D, Schimmelmann BG. 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). J Clin Psychiatry. 2010 Oct;71(10):1313-23. doi: 10.4088/JCP.09m05113yel. Epub 2010 Mar 23.