Placebo controls in clinical trials: concerns about use in relapse prevention studies in schizophrenia

Emsley, Robin; Fleischhacker, W. Wolfgang; Galderisi, Silvana; Halpern, Lisa; McEvoy, Joseph P.; Schooler, Nina R.

doi:10.1136/bmj.i4728

Cited by 5 publications

(2 citation statements)

References 17 publications

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“…Real-world prospective and retrospective studies comparing LAI antipsychotics vs oral antipsychotics generally demonstrate decreases in relapse, hospitalization, and all-cause discontinuation for patients receiving LAI antipsychotics. 70 Although not without controversy, 71 placebo-controlled randomized withdrawal study designs are often used to establish efficacy for the maintenance indication. The typical study design would be one where patients with the disease of interest are stabilized on the test medication and then subsequently randomized to either continue the test medication or receive placebo.…”

Section: Prevention Of Relapse: What Is the Evidence?mentioning

confidence: 99%

Long-acting injectable antipsychotics: what, when, and how

Citrome

2021

CNS Spectr.

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Current guidelines for the treatment of patients with schizophrenia advocate that patients receive treatment with a long-acting injectable (LAI) antipsychotic medication if they prefer such treatment or if they have a history of poor or uncertain adherence. Available LAI formulations in the United States include first-generation antipsychotics (fluphenazine decanoate and haloperidol decanoate), risperidone/paliperidone containing products (risperidone microspheres, paliperidone palmitate, and risperidone subcutaneous), aripiprazole containing products (aripiprazole monohydrate and aripiprazole lauroxil), and olanzapine pamoate. LAI antipsychotics can address the guesswork about adherence status and patients may prefer them if they are offered this as a choice, including individuals early in their disease course. Additional approved indications in the United States for LAI antipsychotics include bipolar I disorder maintenance treatment for risperidone microspheres and aripiprazole monohydrate, and schizoaffective disorder for paliperidone palmitate once monthly. Differences and similarities among the different products are discussed, including guidance regarding optimal treatment selection. Tips are provided to enhance effective patient communication to maximize the likelihood of acceptance of this treatment modality.

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Section: Prevention Of Relapse: What Is the Evidence?mentioning

confidence: 99%

Long-acting injectable antipsychotics: what, when, and how

Citrome

2021

CNS Spectr.

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“…A particular concern is the ongoing use of placebo in relapse-prevention clinical trials in schizophrenia where, contrary to our clinical role and to the principles of beneficence and clinical equipoise, clinicians are complicit in the decision to discontinue active treatment. 10 Most importantly, there is an urgent need for better research exploring alternatives to indefinite treatment with currently available antipsychotic medication, and to investigate whether discontinuation strategies are feasible for any patients, at any stage of the illness.…”

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confidence: 99%