Table of Contents
Trial overview
The trial data provided here describe one interventional study, meaning researchers assigned treatment plans and then measured the results.[1] The study is titled as a randomized, controlled trial of early intensified pharmacological treatment compared with treatment as usual after first-line treatment failure.[1] Lithium is one of the medicines listed in the treatment plans used in this study.[1]
Who was studied
The study included people with schizophrenia, schizoaffective disorder, schizophreniform disorder, major depressive disorder, or bipolar disorder type I or II when they were currently in a depressive episode.[1] The trial focused on people who had a first-time treatment failure on their first-line treatment, which means the first treatment did not work well enough.[1]
The study was divided into different sample groups for different diagnoses, but the overall goal was the same across them.[1] That goal was to see whether early intensified treatment could improve symptoms more than usual care.[1]
What was tested
The main comparison was between an early intensified pharmacological treatment plan and treatment as usual.[1] The trial title and summary show that the study looked at several medicines across different diagnosis groups, and Lithium was included among them.[1]
For patients, this means the study was not testing Lithium alone in the source data provided here.[1] Instead, Lithium was part of a broader treatment strategy being evaluated in people who did not respond well to their first treatment.[1]
Outcomes and measurements
The primary outcome was change in symptom severity from the starting visit to the follow-up visit.[1] The follow-up time was four weeks for major depressive disorder and six weeks for schizophrenia and bipolar depression.[1]
Different rating scales were used based on the condition being studied.[1] For schizophrenia spectrum disorders, the study used the Positive And Negative Syndrome Scale, which measures symptom severity in schizophrenia-related illness.[1] For major depressive disorder and bipolar depression, the study used the Montgomery Asberg Depression Rating Scale, which measures depression symptoms.[1]
Study status and size
The trial status is listed as Withdrawn, which means it did not continue as planned.[1] The planned enrollment was 1254 participants, showing that this was intended to be a large Phase 3 study.[1] The phase was Phase 3, a later stage of research that usually checks how well a treatment works in a larger group of people.[1]
