Protocol for Characterization of Addiction and Dual Disorders: Effectiveness of Coadjuvant Chronotherapy in Patients with Partial Response

Abstract

This protocol aims to characterize patients with dual disorders (DD; comorbid major depression and schizophrenia) compared with patients with only a diagnosis of substance use disorder (SUD) and those with only a diagnosis of severe mental illness (SMI; major depression and schizophrenia), evaluating clinical and personality characteristics, circadian rhythmic functioning, genetic polymorphism and neuropsychological performance in order to obtain a clinical endophenotype of differential vulnerability for these diagnostic entities. Patients will be divided into three groups: DD (45 men with comorbid schizophrenia, 45 men and 30 women with major depression), SUD (n = 90, with a minimum of 30 women) and SMI males (45 with schizophrenia, 45 with major depression). All patients will be under treatment, with at least three months of SUD abstinence and/or with SMI in remission or with stabilized symptoms. Outpatients of both sexes with insufficient restoration of circadian rhythmicity with SUD (n = 30) and dual depression (n = 30) will be asked to participate in a second two-month study, being alternately assigned to the condition of the chronobiological adjuvant approach to the treatment of regular hour habits and exposure to light or to the usual treatment (control). The effect of the intervention and patient compliance will be monitored with a Kronowise KW6® ambulatory device during the first two weeks of treatment and again at weeks 4 and 8 weeks. After completing the evaluation, follow-up of the clinical evolution will be carried out at 3, 6 and 12 months. This project will allow us to analyze the functional impact of DD comorbidity and to develop the first study of chronobiological therapy in the treatment of SUD and dual depression, with results transferable to the clinical setting with cost-effective recommendations for a personalized approach.