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Estudio primario

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Combination of estrogen and antipsychotics in the treatment of women with chronic schizophrenia: a double-blind, randomized, placebo-controlled clinical trial.

Revista Clinical schizophrenia & related psychoses
Año 2013
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INTRODUCTION: Gender differences in schizophrenia include the age of onset, better treatment response, a better outcome, and the peak of the disease in postmenopausal women. Some evidence indicates that these variations are due to estrogen's effect. The intention of this study was to evaluate the effectiveness of estrogen as an adjuvant agent in the treatment of women with chronic schizophrenia. METHODS: Study participants were 32 women of childbearing age with chronic schizophrenia. These patients were hospitalized in an institute for the chronically mentally ill. Participants were randomized into two groups: the first group (16 cases) received conjugated estrogens 0.625 mg/day 4 weeks with their previous antipsychotic treatment, while the second group (16 cases) received placebo booster and antipsychotics. The Positive and Negative Syndrome Scale (PANSS) was used as a measurement tool for assessing psychopathology. RESULTS: The combination of conjugated estrogens with antipsychotic treatment showed a significant decrease in positive (p=0.003), negative (p<0.001), general (p<0.001) and total (p<0.001) PANSS scores over 4 weeks. CONCLUSIONS: Estrogen may be an effective adjuvant agent in the treatment of women with chronic schizophrenia.

Estudio primario

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Weiser M, Burshtein S, Fodoreanu L, et al

Revista Neuropsychopharmacology
Año 2012

Este artículo está incluido en 3 Revisiones sistemáticas Revisiones sistemáticas (3 referencias)

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Estudio primario

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Minocycline benefits negative symptoms in early schizophrenia: a randomised double-blind placebo-controlled clinical trial in patients on standard treatment.

Revista Journal of psychopharmacology (Oxford, England)
Año 2012
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Este artículo está incluido en 2 Revisiones sistemáticas Revisiones sistemáticas (2 referencias)

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The onset and early course of schizophrenia is associated with subtle loss of grey matter which may be responsible for the evolution and persistence of symptoms such as apathy, emotional blunting, and social withdrawal. Such 'negative' symptoms are unaffected by current antipsychotic therapies. There is evidence that the antibiotic minocycline has neuroprotective properties. We investigated whether the addition of minocycline to treatment as usual (TAU) for 1 year in early psychosis would reduce negative symptoms compared with placebo. In total, 144 participants within 5 years of first onset in Brazil and Pakistan were randomised to receive TAU plus placebo or minocycline. The primary outcome measures were the negative and positive syndrome ratings using the Positive and Negative Syndrome Scale. Some 94 patients completed the trial. The mean improvement in negative symptoms for the minocycline group was 9.2 and in the placebo group 4.7, an adjusted difference of 3.53 (s.e. 1.01) 95% CI: 1.55, 5.51; p < 0.001 in the intention-to-treat population. The effect was present in both countries. The addition of minocycline to TAU early in the course of schizophrenia predominantly improves negative symptoms. Whether this is mediated by neuroprotective, anti-inflammatory or others actions is under investigation.

Estudio primario

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Effect of the neuroprotective peptide davunetide (AL-108) on cognition and functional capacity in schizophrenia.

Revista Schizophrenia research
Año 2012
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BACKGROUND: Cognitive dysfunction is a key predictor of functional disability in schizophrenia. Davunetide (AL-108, NAP) is an intranasally administered peptide currently being developed for treatment of Alzheimer's disease and related disorders. This study investigates effects of davunetide on cognition in schizophrenia. METHOD: Sixty-three subjects with schizophrenia received davunetide at one of two different doses (5, 30 mg) or placebo for 12 weeks in a multicenter, double-blind, parallel-group randomized clinical trial. The MATRICS Consensus Cognitive Battery (MCCB) assessed cognitive effects. The UCSD Performance-based Skills Assessment (UPSA) and the Schizophrenia Cognition Rating Scale (SCoRS) assessed functional capacity. Subjects continued their current antipsychotic treatment during the trial. RESULTS: There were no significant differences in MCCB change between davunetide and placebo over the three treatment arms (p=.45). Estimated effect-size (d) values were .34 and .21 favoring the 5 and 30 mg doses vs. placebo, respectively. For UPSA, there was a significant main effect of treatment across study arms (p=.048). Between-group effect size (d) values were.74 and .48, favoring the 5 and 30 mg doses, respectively. No significant effects were observed on the SCoRS or on symptom ratings. No significant side effects or adverse events were observed. CONCLUSION: Davunetide was well tolerated. Effects of davunetide on MCCB-rated cognition were not significant relative to placebo. In contrast, a significant beneficial effect was detected for the UPSA. Based upon effect-size considerations, sample sizes of at least 45-50 subjects/group would be required to obtain significant effects on both MCCB and UPSA, providing guidance for continued clinical development in schizophrenia.

Estudio primario

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Estrogens and men with schizophrenia: is there a case for adjunctive therapy?

Revista Schizophrenia research
Año 2011
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Adjunctive use of estrogen therapy has been shown to be effective in enhancing the treatment of schizophrenia in women. In men, consideration of estrogen therapy has been impacted by concerns of feminising side effects, however, clinical trials of the use of estrogen in treating prostate cancer, bone density loss and even aggression and psychosis in dementia or traumatic brain injury, show this to be a safe and effective therapy. The current 14-day randomised placebo-controlled trial in 53 men with schizophrenia was conducted to evaluate the efficacy of 2 mg oral estradiol valerate as an adjunct to atypical antipsychotic treatment. Results demonstrated for estradiol participants a more rapid reduction in general psychopathology that occurred in the context of greater increases in serum estrogen levels and reductions in FSH and testosterone levels. Approximately 28% of estradiol participants did not achieve an increase (at least a 50% from baseline) in serum estrogen suggesting that further research is needed to refine the type, dose and administration route for estrogen therapy in men. Findings do, however, suggest further exploration of a therapeutic role for adjunctive estradiol treatment in men with schizophrenia is warranted.

Estudio primario

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Celecoxib treatment in an early stage of schizophrenia: Results of a randomized, double-blind, placebo-controlled trial of celecoxib augmentation of amisulpride treatment

Revista Schizophrenia research
Año 2010
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Este artículo está incluido en 8 Revisiones sistemáticas Revisiones sistemáticas (8 referencias)

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Recent trials support the hypothesis of the role of inflammation in the pathogenesis of schizophrenia. The overall therapeutic benefit of anti-inflammatory medication, in particular cyclo-oxygenase-2 (COX-2) inhibitors in schizophrenia, is still controversial. There are suggestions that therapy with COX-2 inhibitors may influence the early stages of the disease. Taking these findings into account, we conducted a double-blind, placebo-controlled, randomized trial of celecoxib augmentation to amisulpride treatment in patients with a first manifestation of schizophrenia. Forty-nine patients diagnosed with schizophrenia were randomly assigned. They were treated either with amisulpride (200-1000. mg) plus celecoxib (400. mg) or amisulpride (200-1000. mg) plus placebo. Inclusion criterion was the diagnosis of schizophrenia during the past two years according to DSM-IV. The trial lasted six weeks. At weekly intervals an assessment of the psychopathology was performed using the Positive and Negative Symptom Scale (PANSS) and the Global Clinical Impression Scale (CGI). A significantly better outcome was observed in the patient group treated with amisulpride plus celecoxib compared to the group with amisulpride plus placebo (PANSS negative: p=0.03; PANSS global; p=0.05 and PANSS total: p=0.02). In addition, ratings by the CGI scale during therapy with amisulpride and celecoxib showed a significantly better result (p≤0.001). A significantly superior therapeutic effect could be observed in the celecoxib group compared to placebo in the treatment of early stage schizophrenia. This is the first time an improvement in patients' negative symptoms has been demonstrated with celecoxib. In future, further trials are needed to investigate the effect of COX-2 inhibitors on prodromal and negative symptoms of schizophrenia. © 2010 Elsevier B.V.

Estudio primario

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A double-blind, randomized study of minocycline for the treatment of negative and cognitive symptoms in early-phase schizophrenia

Revista The Journal of clinical psychiatry
Año 2010
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Este artículo está incluido en 4 Revisiones sistemáticas Revisiones sistemáticas (4 referencias)

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Background: Current antipsychotics have only a limited effect on 2 core aspects of schizophrenia: negative symptoms and cognitive deficits. Minocycline is a second-generation tetracycline that has a beneficial effect in various neurologic disorders. Recent findings in animal models and human case reports suggest its potential for the treatment of schizophrenia. These findings may be linked to the effect of minocycline on the glutamatergic system, through inhibition of nitric oxide synthase and blocking of nitric oxide-induced neurotoxicity. Other proposed mechanisms of action include effects of minocycline on the dopaminergic system and its inhibition of microglial activation. Objective: To examine the efficacy of minocycline as an add-on treatment for alleviating negative and cognitive symptoms in early-phase schizophrenia. Method: A longitudinal double-blind, randomized, placebo-controlled design was used, and patients were followed for 6 months from August 2003 to March 2007. Seventy early-phase schizophrenia patients (according to DSM-IV) were recruited and 54 were randomly allocated in a 2:1 ratio to minocycline 200 mg/d. All patients had been initiated on treatment with an atypical antipsychotic ≤ 14 days prior to study entry (risperidone, olanzapine, quetiapine, or clozapine; 200-600 mg/d chlorpromazine-equivalent doses). Clinical, cognitive, and functional assessments were conducted, with the Scale for the Assessment of Negative Symptoms (SANS) as the primary outcome measure. Results: Minocycline was well tolerated, with few adverse events. It showed a beneficial effect on negative symptoms and general outcome (evident in SANS, Clinical Global Impressions scale). A similar pattern was found for cognitive functioning, mainly in executive functions (working memory, cognitive shifting, and cognitive planning). Conclusions: Minocycline treatment was associated with improvement in negative symptoms and executive functioning, both related to frontal-lobe activity. Overall, the findings support the beneficial effect of minocycline add-on therapy in early-phase schizophrenia. Trial Registration: clinicaltrials.gov Identifier: NCT00733057. © Copyright 2010 Physicians Postgraduate Press, Inc.

Estudio primario

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Adjuvant aspirin therapy reduces symptoms of schizophrenia spectrum disorders: Results from a randomized, double-blind, placebo-controlled trial

Revista The Journal of clinical psychiatry
Año 2010
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Este artículo está incluido en 6 Revisiones sistemáticas Revisiones sistemáticas (6 referencias)

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Objective: Inflammatory processes may play a role in the pathophysiology of schizophrenia. The aim of this study was to determine the efficacy of adjuvant treatment with aspirin (acetylsalicylic acid) in schizophrenia spectrum disorders. Method: This randomized, double-blind, placebo-controlled study was conducted between May 2004 and August 2007. Seventy antipsychotic-treated inpatients and outpatients from 10 psychiatric hospitals in The Netherlands with a DSM-IV-diagnosed schizophrenia spectrum disorder were included. Patients were randomized to adjuvant treatment with aspirin 1000 mg/d or placebo. During a 3-month follow-up, psychopathology was assessed with the Positive and Negative Syndrome Scale (PANSS). Other assessments included cognitive tests and immune function. The primary efficacy outcome was the change in total PANSS score. Secondary outcomes were changes in the PANSS subscales and cognitive test results. Results: Mixed-effect models showed a 4.86-point (95% CI, 0.91 to 8.80) and 1.57-point (95% CI, 0.06 to 3.07) larger decrease in the aspirin group compared to the placebo group on the total and positive PANSS score, respectively. Similar but not statistically significant results were observed for the other PANSS subscale scores. Treatment efficacy on total PANSS score was substantially larger in patients with the more altered immune function (P = .018). Aspirin did not significantly affect cognitive function. No substantial side effects were recorded. Conclusion: Aspirin given as adjuvant therapy to regular antipsychotic treatment reduces the symptoms of schizophrenia spectrum disorders. The reduction is more pronounced in those with the more altered immune function. Inflammation may constitute a potential new target for antipsychotic drug development. Trial Registration: controlled-trials.com Identifier: ISRCTN27745631. © Copyright 2010 Physicians Postgraduate Press, Inc.

Estudio primario

No clasificado

N-acetil cisteína como un precursor del glutatión para la esquizofrenia - un estudio doble ciego, aleatorizado, controlado con placebo.

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Revista Biological psychiatry
Año 2008
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Este artículo está incluido en 4 Revisiones sistemáticas Revisiones sistemáticas (4 referencias)

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ANTECEDENTES: los niveles de glutatión cerebrales se redujeron en la esquizofrenia, un trastorno que a menudo es crónica y refractaria al tratamiento. N-acetilcisteína (NAC) aumenta el glutatión cerebral en roedores. Este estudio se realizó para evaluar la seguridad y eficacia de la NAC por vía oral (1 g por vía oral dos veces al día [la oferta]) como un complemento a la medicación de mantenimiento para el tratamiento de la esquizofrenia crónica durante un período de 24 semanas. MÉTODOS: Un estudio multicéntrico, doble ciego, aleatorizado, controlado con placebo. La lectura principal fue el cambio desde la línea base en lo positivo y síntomas negativos Scale (PANSS) y sus componentes. lecturas secundarias incluyeron la Impresión Clínica Global (CGI) escalas de gravedad y mejora, así como escalas de funcionamiento general y de calificación extrapiramidal. Se evaluaron los cambios después de una interrupción del tratamiento de 4 semanas. Ciento cuarenta personas con esquizofrenia crónica en el mantenimiento de la medicación antipsicótica se asignaron al azar; 84 completaron el tratamiento. RESULTADOS: intención de tratar el análisis revelaron que los sujetos tratados con NAC mejoraron más que los sujetos tratados con placebo durante el período de estudio en el total de la PANSS [-5.97 (-10.44, -1.51), p = 0,009], PANSS negativa [diferencia de medias -1,83 (95% intervalo de confianza: -3.33, -.32), p = 0,018], y PANSS general [-2.79 (-5.38, -.20), p = 0,035], CGI-Severidad (CGI-S ) [-.26 (-.44, -.08), p = 0,004], y CGI-Improvement (CGI-I) [-.22 (-.41, -.03), p = .025] Las puntuaciones . No se observó ningún cambio significativo en la subescala positiva de la PANSS. tratamiento N-acetil cisteína también se asoció con una mejora en la acatisia (p = 0,022). Los tamaños del efecto en el punto final fueron consistentes con beneficios moderados. Conclusiones Estos datos sugieren que el adyuvante NAC tiene potencial como estrategia de aumento seguro y moderadamente eficaz para la esquizofrenia crónica.

Estudio primario

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Estrogen in severe mental illness: a potential new treatment approach.

Revista Archives of general psychiatry
Año 2008
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Este artículo está incluido en 2 Revisiones sistemáticas Revisiones sistemáticas (2 referencias)

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CONTEXT: Accumulating evidence suggests that estrogens may have therapeutic effects in severe mental illnesses, including schizophrenia, via neuromodulatory and neuroprotective activity. OBJECTIVE: To compare the efficacy of adjunctive transdermal estradiol with that of adjunctive placebo in the treatment of acute psychotic symptoms. DESIGN: Randomized, double-blind study. SETTING: Patients were recruited from inpatient acute hospital wards and outpatient clinics of 2 metropolitan Melbourne general hospitals. PARTICIPANTS: One hundred two women of childbearing age with schizophrenia. All participants were in an acute or chronic phase of their illness; 73 participants were outpatients and the rest were inpatients. Intervention Patients were randomized to receive 100 microg of transdermal estradiol (n = 56) or transdermal placebo (n = 46) for 28 days. MAIN OUTCOME MEASURES: Psychopathological symptoms were assessed weekly with the Positive and Negative Syndrome Scale. RESULTS: The addition of 100 microg of transdermal estradiol significantly reduced positive (P < .05) and general psychopathological (P < .05) symptoms during the 28-day trial period compared with women receiving antipsychotic medication alone. CONCLUSION: Estradiol appears to be a useful treatment for women with schizophrenia and may provide a new adjunctive therapeutic option for severe mental illness. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT00206570.