Caroff 2011.
Methods | Allocation: "randomly assigned", not described
Blindness: "double blind", partially described.
Design: post hoc analysis of parallel‐group RCT
Setting: inpatients, USA Duration: 18 months |
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Participants | Diagnosis: schizophrenia and TD (DSM IV, Schooler‐Kane criteria)
N = 200
Age: 47.2 (SD 9.4) years (18‐65 years)
Sex: 158 men and 42 women History: duration of TD not reported |
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Interventions | Overlap in administration of the antipsychotic drugs that participants received before study entry was permitted for the first 4 weeks after randomisation to allow a gradual transition to study medication: 1. Oolanzapine: flexible dose of 7.5 mg each day/twice a day/3 times a day/4 times a day for 18 months. N = 54 2. quetiapine: flexible dose of 200 mg each day/twice a day/3 times a day/4 times a day for 18 months. N = 62 3. Rrisperidone: flexible dose of 1.5 mg each day/twice a day/3 times a day/4 times a day for 18 months. N = 56 4. ziprasidone: flexible dose of 40 mg each day/twice a day/3 times a day/4 times a day for 18 months. N = 28 Medications were flexibly dosed with 1‐4 capsules daily, as judged by the study doctor. Concomitant medications were permitted, except for additional antipsychotic agents. |
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Outcomes | Leaving the study early Unable to use ‐ AIMS, PANSS, SAS, BAS, cogitive composite score (not reported in means and SDs for the separate intervention groups)* |
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Notes | Sponsorship source: supported by the Clinical Antipsychotic Trials of Intervention Effectiveness (CATIE) project, National Institute of Mental Health. This article was based on results from the CATIE project, supported by the National Institute of Mental Health. Astra Zeneca Pharmaceuticals LP, Bristol‐Myers Squibb Company, Forest Pharmaceuticals, Inc., Janssen Pharmaceutica Products, L.P., Eli Lilly and Company, Otsuka Pharmaceutical Co., Ltd., Pfizer Inc., and Zenith Goldline Pharmaceuticals, Inc., provided medications for the studies. This material is based upon work also supported in part by the Department of Veterans Affairs, Veterans Health Administration, Office of Research Development, with resources and the use of facilities at the Philadelphia Veterans Affairs Medical Center. *Study author kindly replied to our request for data. At the time of preparing this review no more outcome data were available. |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | "Patients were initially randomly assigned", further details not reported |
Allocation concealment (selection bias) | Unclear risk | Allocation concealment not reported |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | "...double‐blind conditions..." "Identical‐appearing capsules contained olanzapine (7.5 mg), quetiapine (200 mg), risperidone (1.5 mg), perphenazine (8 mg), or ziprasidone (40 mg)." |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Blinding of outcome assessors not reported |
Incomplete outcome data (attrition bias) All outcomes | High risk | The primary clinical outcome measure was time to all‐cause treatment discontinuation. Total population (N = 200): 74% discontinuation olanzapine: 31/54 (57%); quetiapine: 51/62 (82%); risperidone: 44/56 (79%); zipraidone: 21/28 (75%). Reasons for withdrawal reported |
Selective reporting (reporting bias) | High risk | Original CATIE study: "The primary clinical outcome measure was time to all‐cause treatment discontinuation. Secondary outcomes included discontinuations for intolerability, inefficacy, and patient decision; rates of discontinuations; mean modal dose; and change from baseline in the PANSS and neurocognitive composite scores/".TD: "The primary outcome measure used to evaluate the course of TD was change from baseline in total AIMS score. Secondary outcome measures included change in global, distress, and impairment of function items on the AIMS; percentage of patients meeting Schooler‐Kane criteria for at least 2 consecutive visits post baseline; percentage of visits at which patients met modified Schooler‐Kane criteria; and percentage of patients with at least a 50% change in AIMS score (excluding month 1). In addition, treatment differences with respect to all cause discontinuation are described for patients with TD at baseline." |
Other bias | High risk | Post hoc analysis; modified diagnostic criteria for TD were applied at baseline, and a 3‐month history of antipsychotics exposure was not required. |