Four out of 18 patients in antipsychotic monotherapy, 5 out of 16 individuals receiving psychological intervention, and 5 out of 17 receiving combined therapy achieved a good clinical response at 6 months.
There is a dearth of evidence showing the effectiveness of treatments in early-onset psychosis, with the current standard guidance for early-onset psychosis generally extrapolated from trials in adult populations.
A team, led by Anthony P. Morrison, ClinPsyD, Division of Psychology and Mental Health, University of Manchester, established the feasibility of a randomized controlled trial of antipsychotic monotherapy, psychological intervention monotherapy, and antipsychotics combined with psychological intervention in adolescents with first-episode psychosis.
The UK National Institute for Health and Care Excellence has recommended the evaluation of the clinical effectiveness and cost-effectiveness of antipsychotic drugs in comparison to psychological interventions such as cognitive behavioral therapy (CBT) and family intervention, as well as a combination of these treatments.
In the multicenter, pilot and feasibility trial, the investigators recruited 61 individuals from 7 UK National Health Service Trust sites between 14-18 years old.
Each patient was seeking help, showed current psychotic symptoms, and met ICD-10 criteria for schizophrenia, schizoaffective disorder, or delusional disorder, or met the entry criteria for an early intervention for psychosis service.
Each participant was assigned equally to either antipsychotics, psychological intervention consisting of CBT with optional family intervention, or antipsychotics with psychological intervention.
The randomization was conducted through a web-based randomization system with permuted blocks of random size, stratified by center and family contact. CBT consisted of 26 sessions over 6 months along with 4 booster sessions. Family intervention included up to 6 sessions over the course of 6 months.
The choice and dose of antipsychotic were at the discretion of the treating consultant psychiatrist.
Each individual was followed for a maximum of 12 months.
The investigators sought primary outcomes of feasibility and a proposed primary efficacy outcome of the total score on the Positive and Negative Syndrome Scale (PANSS) at 6 months.
The primary outcomes were analyzed by the intention to treat and safety outcomes were reported according to as-treated status, for all patients who had received at least 1 CBT session or family intervention or at least 1 dose of antipsychotics.
The study had a low referral to recruitment ration, but a high rate of retention (n = 51; 84%) at the six-month primary endpoint, a high rate of adherence to psychological intervention, which was defined as 6 or more sessions of CBT (n = 32; 82%) in the monotherapy and combined groups.
There was also a moderate rate of adherence to antipsychotic medication, defined as at least 6 consecutive weeks of exposure (n = 28; 65%) in the monotherapy and combined groups.
The mean scores for PANSS total at the primary endpoint was 68.6 (SD, 17.3) for antipsychotic monotherapy, which was 6.2 points lower than at randomization, 59.8 (SD, 13.7) for psychological intervention, which was 13.1 points lower at baseline, and 62.0 (SD, 15.9) for antipsychotics with psychological intervention, 13.9 points lower than at randomization.
Four out of 18 patients in antipsychotic monotherapy, 5 out of 16 individuals receiving psychological intervention, and 5 out of 17 receiving combined therapy achieved a good clinical response at 6 months, defined as at least a 50% improvement in PANSS total score.
For the as-treated groups, serious adverse events occurred in 35% (n = 8) of patients in the combined group, 13% (n = 2) of individuals in the antipsychotics group, 24% (n = 4) of patients in the psychological intervention group, and 80% (n = 4) participants who did not receive any treatment.
There were no serious adverse events considered related to participation in the trial.
“This trial is the first to show that a head-to-head clinical trial comparing psychological intervention, antipsychotics, and their combination is safe in young people with first-episode psychosis,” the authors wrote. “However, the feasibility of a larger trial is unclear because of site-specific recruitment challenges, and amendments to trial design would be needed for an adequately powered clinical and cost-effectiveness trial that provides robust evidence.”
The study, “Antipsychotic medication versus psychological intervention versus a combination of both in adolescents with first-episode psychosis (MAPS): a multicentre, three-arm, randomised controlled pilot and feasibility study,” was published online in The Lancet Psychiatry.