Simvastatin augmentation for recent-onset psychotic disorder: A study protocol

Begemann, Marieke J H; Schutte, Maya; Slot, Margot I. E.; Doorduin, Janine; Bakker, P. Roberto; Haren, Neeltje E.M. van; Sommer, Iris E.

doi:10.1016/j.bbacli.2015.06.007

Cited by 23 publications

(25 citation statements)

References 39 publications

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“…We included 97 patients with schizophrenia spectrum disorder, 136 patients with bipolar-I disorder, 35 individuals with subclinical psychotic experiences, and 219 healthy controls. Participants were recruited between 2006 and 2018 via the Dutch Bipolar Cohort (BD, HC 4 , 46 ), The Outcome of Psychosis Fitness Therapy (SCZ, HC 47 ), the Spectrum (SCP, SCZ, HC 48 ), the Understanding Hallucinations (SCZ, HC; clinicaltrials.gov identifier NCT02460965), or the Simvastatin for recent onset psychosis studies (SCZ, HC 49 ). All participants were above 18 years and had no diagnosis of alcohol or substance abuse disorders or somatic disorders (e.g., cardiovascular, neuromuscular, or endocrine disorders) 47 , 48 .…”

Section: Methodsmentioning

confidence: 99%

“…All participants were above 18 years and had no diagnosis of alcohol or substance abuse disorders or somatic disorders (e.g., cardiovascular, neuromuscular, or endocrine disorders) 47 , 48 . The SCZ group had a diagnosis of schizophrenia, schizophreniform disorder, or psychosis not otherwise specified according to the DSM-IV 1 , had a lifetime history of hallucinations and/or delusions (as assessed by the Structured Clinical Interview for DSM-IV, SCID-I 50 , and the Comprehensive Assessment of Symptoms and History Interview, CASH 51 ) and was stable on antipsychotic medication for at least 4 weeks before inclusion 47 , 49 . Subjects with a diagnosis of schizoaffective disorder ( N = 12, 11%) were excluded to ensure contrast in the comparison between SCZ and BD.…”

Section: Methodsmentioning

confidence: 99%

“…Data studied in this manuscript have been described previously [46][47][48][49] (DOIs: https://doi.org/ 10.1017/S0033291715002299; https://doi.org/10.1016/j.euroneuro.2012.08.008; https://doi. org/10.1093/schbul/sbn130; https://doi.org/10.1016/j.bbacli.2015.06.007).…”

Section: Antipsychotic Medication Effects On Mst Measuresmentioning

confidence: 99%

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Functional brain networks in the schizophrenia spectrum and bipolar disorder with psychosis

et al. 2020

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Psychotic experiences have been proposed to lie on a spectrum, ranging from subclinical experiences to treatment-resistant schizophrenia. We aimed to characterize functional connectivity and brain network characteristics in relation to the schizophrenia spectrum and bipolar disorder with psychosis to disentangle neural correlates to psychosis. Additionally, we studied antipsychotic medication and lithium effects on network characteristics. We analyzed functional connectivity strength and network topology in 487 resting-state functional MRI scans of individuals with schizophrenia spectrum disorder (SCZ), bipolar disorder with a history of psychotic experiences (BD), treatment-naïve subclinical psychosis (SCP), and healthy controls (HC). Since differences in connectivity strength may confound group comparisons of brain network topology, we analyzed characteristics of the minimum spanning tree (MST), a relatively unbiased backbone of the network. SCZ and SCP subjects had a lower connectivity strength than BD and HC individuals but showed no differences in network topology. In contrast, BD patients showed a less integrated network topology but no disturbances in connectivity strength. No differences in outcome measures were found between SCP and SCZ, or between BD patients that used antipsychotic medication or lithium and those that did not. We conclude that functional networks in patients prone to psychosis have different signatures for chronic SCZ patients and SCP compared to euthymic BD patients, with a limited role for medication. Connectivity strength effects may have confounded previous studies, as no functional network alterations were found in SCZ after strict correction for connectivity strength.

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Section: Methodsmentioning

confidence: 99%

Section: Methodsmentioning

confidence: 99%

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Functional brain networks in the schizophrenia spectrum and bipolar disorder with psychosis

et al. 2020

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“…Overview The study procedures described in this paper are comparable to procedures described in a previously published paper by our group related to another randomized clinical trial (RCT) [40]. However, there are essential differences between both studies, such as treatment duration, duration of the trial itself, and an interview used to determine the diagnosis of the participant as well as the intervention.…”

Section: Methodsmentioning

confidence: 99%

Prednisolone versus placebo addition in the treatment of patients with recent-onset psychotic disorder: A trial design

Nasib

Sommer

Rossum

et al. 2019

Preprint

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Background: The symptom severity of a substantial group of schizophrenia patients (30-40%) does not improve through pharmacotherapy with antipsychotic medication, indicating a clear need for new treatment options to improve schizophrenia outcome. Meta-analyses, genetic studies, randomized controlled trials and post-mortem studies suggest that immune dysregulation plays a role in the pathophysiology of schizophrenia. Some anti-inflammatory drugs have shown beneficial effects on the symptom severity of schizophrenia patients.. Corticosteroids are effective in various chronic inflammatory and auto-immune disorders. From the group of glucocorticosteroids, prednisolone has minor mineral-corticosteroid potencies, can adequately pass the blood-brain barrier (BBB) and its side-effects and safety profile are well known. Therefore, a study into treatment with prednisolone can provide as a proof of concept for immune modulation as a treatment for schizophrenia. Method: In total 90 subjects, aged 18-70 years, diagnosed with schizophrenia, schizoaffective or schizophreniform disorder (Diagnostic and Statistical Manual of Mental Disorders-IV (DSM-IV) 295.*) or psychosis NOS (not otherwise specified) (298.9) will be included. The time interval between the onset of psychosis and study entry should not exceed seven years. Patients will be randomized 1:1 to either prednisolone or placebo daily for a period of 6 weeks. Study medication will be initiated at 40 mg for three days, after which it will be tapered down within 6 weeks after initiation, following current treatment guidelines. Primary outcome is change in symptom severity, expressed as change in total score on the Positive and Negative Symptom Scale (PANSS) from baseline to end of treatment. Cognitive functioning (measured through the Brief Assessment of Cognition in Schizophrenia; BACS) and change in Global Assessment Functioning (GAF) will be assessed, in addition to various immunological biomarkers. Secondary outcomes are a 4- and 6-month follow-up assessment of PANSS, BACS, GAF scores and immunological biomarkers. Additionally, a subgroup of patients can participate in the magnetic resonance imaging (MRI) part of the study where MR spectroscopy, structural, functional and diffusion MRI will be conducted. Discussion: It is expected that prednisolone addition to current antipsychotic medication use will reduce symptom severity and will improve cognition when compared to placebo. Trial registration: ClinicalTrails.gov NCT02949232 registered at 31 October 2016, retrospectively registered https://clinicaltrials.gov/ct2/show/NCT02949232?term=corticosteroid&cond=schizophrenia&rank=3 ; EudraCT-number 2014-000520-14 and 2017-000163-32.

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“…In the second trial with 36 total participants, 20mg per day of adjunct lovastatin for 8.5 weeks did not lead to any significant improvement in PANSS measures compared to placebo [87]. There is a third trial currently underway which plans to determine the effects of adjunct treatment with 40mg/day simvastatin in 250 participants with schizophrenia for a period of 12 month [88]. …”

Section: Treatmentsmentioning

confidence: 99%