A multicenter pilot and feasibility study of a randomized, single-blind, 3-arm, controlled trial for the treatment of adolescents (ages 14-18 years) presenting with first episode psychosis had a low recruitment rate, but high retention and adherence for the participating patients. These findings were published in the Lancet Psychiatry.1
Anthony P. Morrison, ClinPsyD, of the Psychosis Research Unit, Greater Manchester Mental Health National Health Service (NHS) Foundation Trust, Prestwich, United Kingdom, and colleagues recruited patients from 7 NHS Trust sites. Patients were eligible if they had first episode psychosis within the previous year, were being cared for by a psychiatrist, had current psychotic symptoms, met the criteria for psychosis services, and/or met criteria for schizophrenia, schizoaffective disorder, or delusional disorder.
Patients (n=61) were randomly assigned in a 1:1:1 ratio to receive antipsychotic medication (n=22), a psychological intervention involving cognitive behavioral therapy (CBT) with optional family intervention (n=18), or antipsychotic medication plus psychological intervention (n=21). Antipsychotic medication was prescribed at the discretion of the treating psychiatrist. CBT continued for up to 26 sessions over 6 months plus 4 booster sessions. Family intervention continued for up to 6 sessions over 6 months.
The participants had a mean age of 16.3 years (standard deviation [SD], 1.3 years) and were recruited between April 10, 2017 and October 31, 2018. They were followed for up to 1 year.
The study observed a high rate of retention of the participants (84%) at 6-months. Psychological intervention adherence as defined by 6 or more sessions was higher (82%) than antipsychotic medication adherence (65%).
The Positive and Negative Syndrome Scale (PANSS) at 6 months was 68.6 (SD, 17.3) for the antipsychotic monotherapy, 59.8 (SD, 13.7) for the psychological intervention monotherapy, and 62.0 (SD, 15.9) for the combined therapy. The reduction in PANSS scores when compared with baseline for each group was 6.2, 13.1, and 13.9 for the antipsychotic monotherapy, psychological intervention monotherapy, and dual therapy, respectively.
Adverse events, including voluntary psychiatric admission, suicide attempt, serious violent incident, voluntary admission to a general medical ward, overdose of medication or painkillers, were highest (35%) among the combined group compared to the monotherapies (antipsychotic medication, 13%; psychological intervention, 24%).
In an editorial published in Lancet Psychiatry, Sameer Jauhar, PhD, of the Institute of Psychiatry, Psychology and Neuroscience, King’s College London, United Kingdom, highlighted some of the limitations of the study.2 He noted, “at first look, this study is a welcome addition to the sparse literature and should be followed by a larger trial. However, on closer inspection, the trial raises as many questions as it answers.”
The trial failed to conduct diagnostic interviews at baseline, instead choosing to include any individual experiencing first time psychosis, indicating that individuals with hallucinations caused by differing underlying conditions, for instance schizophrenia or posttraumatic stress disorder, were being treated and expected to react in the same manner. The trial also failed to implement a placebo group, and as all groups experienced adverse effects, Dr Jauhar asserted that it was difficult to know the magnitude of these adverse effects.
Dr Jauhar2 concluded a larger trial “will need to focus on clinically homogenous groups and differentiate treatment effects. This line of investigation might take time and more than one study, but the results would have wide-ranging and lasting consequences.”
Disclosure: Multiple authors declared affiliations with industry. Please refer to the original abstract for a full list of disclosures.
1. Morrison A P, Pyle M, Maughan D, et al. Antipsychotic medication versus psychological intervention versus a combination of both in adolescents with first-episode psychosis (MAPS): a mulicentre, three-arm, randomised controlled pilot and feasibility study. [Published online July 7, 2020] Lancet Psychiatry doi:10.1016/S2215-0366(20)30248-0.
2. Jauhar S. Psychosocial interventions versus antipsychotics for early-onset psychosis: can we fill the evidence gap? [Published online July 7, 2020] Lancet Psychiatry doi:10.1016/S2215-0366(20)30296-0.