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Probiotic Formulation for Patients With Bipolar or Schizophrenia Spectrum Disorder: A Double-Blind, Randomized Placebo-Controlled Trial
Abstract
Background and Hypothesis
Probiotic augmentation offers a promising treatment for bipolar disorder (BD) and schizophrenia spectrum disorder (SSD). By targeting microbiome deviations, they may improve both gut and brain health.
Study Design
In this double-blind, randomized, placebo-controlled trial with the multi-strain probiotic formulation Ecologic BARRIER, we aimed to improve psychiatric and cognitive symptoms, intestinal permeability, and gastrointestinal symptoms in patients with BD or SSD. A total of 131 patients were randomized 1:1 to receive either the probiotic supplement (n = 67) or a placebo (n = 64) for 3 months, in addition to treatment-as-usual. The primary outcomes were symptom severity assessed by the Brief Psychiatric Rating Scale and cognitive functioning by the Brief Assessment of Cognition in Schizophrenia.
Study Results
No significant effect of probiotics was observed on psychiatric symptoms, but borderline significant improvement was observed in the cognition category of verbal memory (Linear Mixed Model (LMM) 0.33; adjusted P = .059). Probiotics beneficially affected markers of intestinal permeability and inflammation, including zonulin (LMMserum = −18.40; adjusted P = .002; LMMfecal = −10.47; adjusted P = .014) and alpha-1 antitrypsin (LMM 9.26; adjusted P = .025). Indigestion complaints significantly decreased in male participants in the probiotics group (LMM = −0.70; adjusted P = .010). Adverse events were similar between groups.
Conclusions
Our study observed significant advantages of probiotics for gut health in BD and SSD, with excellent safety and tolerability. A borderline effect on verbal memory was also indicated. These results underscore the need for further research into microbiome-targeted interventions for patients with complex brain disorders.
Journal Article
Adolescent schizophrenia
\"Schizophrenia is a chronic disorder that impacts a broad range of a person's social and developmental functioning. Until the recent past, most of the research done on schizophrenia did not include children or adolescents who suffer from the disorder. During adolescence, important changes take place in brain development. These changes make adolescence a period of both vulnerability and opportunity. Emergence of psychosis and schizophrenia may be associated with abnormal brain development during adolescence. This book discusses the findings of studies that focus on abnormal brain development during the premorbid period of psychosis and schizophrenia. Cognitive neuroscience constructs of visuospatial memory and working memory are associated with adult- and adolescent-onset schizophrenia. This book reviews the existing literature on the topic and explores the nature of and association between visuospatial memory in adolescent onset schizophrenia.\"--Preface.
Book
Efficacy and safety of clozapine in psychotic disorders—a systematic quantitative meta-review
A recent increase in the literature regarding the evidence base for clozapine has made it increasingly difficult for clinicians to judge “best evidence” for clozapine use. As such, we aimed at elucidating the state-of-the-art for clozapine with regard to efficacy, effectiveness, tolerability, and management of clozapine and clozapine-related adverse events in neuropsychiatric disorders. We conducted a systematic PRISMA-conforming quantitative meta-review of available meta-analytic evidence regarding clozapine use. Primary outcome effect sizes were extracted and transformed into relative risk ratios (RR) and standardized mean differences (SMD). The methodological quality of meta-analyses was assessed using the AMSTAR-2 checklist. Of the 112 meta-analyses included in our review, 61 (54.5%) had an overall high methodological quality according to AMSTAR-2. Clozapine appears to have superior effects on positive, negative, and overall symptoms and relapse rates in schizophrenia (treatment-resistant and non-treatment-resistant subpopulations) compared to first-generation antipsychotics (FGAs) and to pooled FGAs/second-generation antipsychotics (SGAs) in treatment-resistant schizophrenia (TRS). Despite an unfavorable metabolic and hematological adverse-event profile compared to other antipsychotics, hospitalization, mortality and all-cause discontinuation (ACD) rates of clozapine surprisingly show a pattern of superiority. Our meta-review outlines the superior overall efficacy of clozapine compared to FGAs and most other SGAs in schizophrenia and suggests beneficial efficacy outcomes in bipolar disorder and Parkinson’s disease psychosis (PDP). More clinical studies and subsequent meta-analyses are needed beyond the application of clozapine in schizophrenia-spectrum disorders and future studies should be directed into multidimensional clozapine side-effect management to foster evidence and to inform future guidelines.
Journal Article
Pharmacologic Augmentation of Computerized Auditory Training in Chronic Psychosis: Preliminary Findings From a Single-Site, Double-Blind Study
Abstract
Background
Computerized auditory training (AT) modestly improves symptoms, cognition, and functioning in schizophrenia. We assessed whether d-amphetamine (AMPH) or memantine (MEM) can enhance gains from 30-h of AT.
Methods
Antipsychotic-medicated individuals with chronic psychosis (n = 68; mean age 47.03y; M:F = 39:29) completed up to 30 AT sessions (2-3/week; n = 50 completed 30 sessions) in 3 groups: “AMPH group” (AMPH (5 mg po) 1-h before each AT session); “MEM group” (titrated to 10 mg MEM bid and maintained that dose throughout training); “PBO group” (PBO dosed identically to either AMPH or MEM). Primary (PANSS total, MCCB Composite, WHODAS) and secondary (PANSS positive, PANSS negative, YMRS, PHQ-9, PSYRATS) outcome measures were acquired at baseline, after 10, 20, and 30 AT sessions, and 12 weeks post-training. Pill identity (active/PBO) was blind to subjects and staff.
Results
Marginally significant between-group gains for AMPH vs PBO were detected for one of three primary outcomes (WHODAS, P =.050; but not PANSS total or MCCB Composite), and for 3 of 5 secondary clinical outcomes (PANSS positive, YMRS, PSYRATS, P’s≤.027–.049). Within-subject gains over time were detected for primary and secondary clinical measures for AMPH (P’s≤.014–.004) and MEM (P’s≤.02–.001) groups; some of these would not survive conservative correction for multiple comparisons. No measures detected symptom worsening; treatment satisfaction exceeded subjects’ expectations.
Conclusions
Results are mixed; drug-associated gains in several measures vs PBO suggest that these regimens may augment AT-induced functional and clinical improvement in psychosis patients, independent of changes in neurocognition. Assessment in larger samples seems warranted.
Journal Article
Joining psychiatric care and faith healing in a prayer camp in Ghana: randomised trial
Care of people with serious mental illness in prayer camps in low-income countries generates human rights concerns and ethical challenges for outcome researchers. Aims To ethically evaluate joining traditional faith healing with psychiatric care including medications (Clinical trials.gov identifier NCT02593734).
Residents of a Ghana prayer camp were randomly assigned to receive either indicated medication for schizophrenia or mood disorders along with usual prayer camp activities (prayers, chain restraints and fasting) (n = 71); or the prayer camp activities alone (n = 68). Masked psychologists assessed Brief Psychiatric Rating Scale (BPRS) outcomes at 2, 4 and 6 weeks. Researchers discouraged use of chaining, but chaining decisions remained under the control of prayer camp staff.
Total BPRS symptoms were significantly lower in the experimental group (P = 0.003, effect size -0.48). There was no significant difference in days in chains.
Joining psychiatric and prayer camp care brought symptom benefits but, in the short-run, did not significantly reduce days spent in chains. Declaration of interest None.
Journal Article
Effect of Long-Term Tai Chi Therapy on the Immune-Inflammatory Pathway in Patients with Schizophrenia with Antipsychotic-Stabilized
The primary objective of this study was to explore the influence of prolonged (24 weeks) supplementary Tai Chi therapy on cognitive capabilities and immune-inflammatory pathways in subjects diagnosed with schizophrenia. A total of 90 individuals who have been clinically diagnosed with schizophrenia were assigned to two treatment groups, namely the Tai Chi treatment (TT) group and the routine treatment (RT) group. Following a 24-week duration of intervention, the data obtained from 32 patients in the TT group and 30 patients in the RT group were meticulously analyzed. At the commencement of the investigation and upon completion of the 24-week intervention, blood samples were gathered, and clinical evaluations were executed. In plasma, the identification of nine cytokines (IL-10, IFN-γ, IL-5, GM-CSF, TNF-α, IL-13, IL-4, IL-2, and IL-12) was conducted using the multiple primer suspension chip method. The clinical evaluations encompassed CGI, WHOQUOL-BREF, SOFS, PSS, BPRS, SAPS, SANS, and RBANS. In comparison to the RT group, the patients in the TT group demonstrated decreased levels of TNF-α and IL-5 (
P
< 0.05). Moreover, they encountered more pronounced advancements in SAPS, SANS, PSS, SOFS, and RBANS scores (
P
< 0.05). Additionally, a positive connection was detected between the plasma TNF-α level in the TT group and both the SANS score and the SPFS score (
P
< 0.05). Tai Chi has been shown to improve clinical symptoms in patients with schizophrenia as an add-on therapy, potentially through its effects on immunomodulatory pathways.
Journal Article