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OBJECTIVE: The treatment of bipolar depression remains challenging due to the limited effective and safe therapeutic options available; thus, developing newer treatments that are effective and well tolerable is an urgent unmet need. The objective of the present trial was to test 150 to 300 mg/day of cannabidiol as an adjunctive treatment for bipolar depression. METHOD: A randomized, double-blind, placebo-controlled pilot study to assess the efficacy of adjunctive cannabidiol in bipolar depression was used. Efficacy parameters were changes in the Montgomery-Åsberg Depression Rating Scale (MADRS) from baseline to week 8. Secondary outcomes included response and remission rates, changes in anxiety and psychotic symptoms, and changes in functioning. Patients continued double-blind treatment until week 12 to monitor for adverse effects, laboratory analysis, and manic symptoms. Study registry: NCT03310593. RESULTS: A total of 35 participants were included. MADRS scores significantly decreased from baseline to the endpoint (placebo, -14.56; cannabidiol, -15.38), but there was no significant difference between the groups. Similarly, there were no other significant effects on the secondary outcomes. However, an exploratory analysis showed a significant effect of cannabidiol 300 mg/day in reducing MADRS scores from week 2 to week 8 (placebo, -6.64; cannabidiol, -13.72). There were no significant differences in the development of manic symptoms or any other adverse effects. CONCLUSION: Cannabidiol did not show significantly higher adverse effects than placebo. Despite the negative finding on the primary outcome, an exploratory analysis suggested that cannabidiol should be further studied in bipolar depression in higher doses of at least 300 mg/day and under research designs that could better control for high placebo response.

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Resumo O Ensaio Clínico Aleatorizado (ECA) é considerado o tipo de desenho metodológico com maior poder de verificação da eficácia das psicoterapias. Entretanto, especialmente a partir da segunda metade do século XX, muitas críticas direcionadas às concepções epistemológicas subjacentes às ditas "ciências duras" atingiram também, no âmbito das ciências da saúde, os estudos que adotavam esse desenho. Este artigo é uma reflexão crítica sobre algumas das objeções feitas aos ECAs, avaliando de que maneira e até que ponto estes poderiam se configurar como estratégia válida de investigação científica no contexto crítico apontado. Conclui-se que o ECA pode e deve ser utilizado - desde que em contexto crítico - por seu valor pragmático, enquanto produtor de predições e intervenções capazes de solucionar problemas clínicos, inevitavelmente definidos e estabelecidos a partir do ponto de vista particular de uma comunidade.

Abstract The randomized controlled clinical trial (RCT) is considered the type of methodological design with the greatest power to verify the efficacy of psychotherapies. However, especially from the second half of the twentieth century, many criticisms directed at the epistemological conceptions underlying the so-called "hard sciences" have also affected the studies that adopted this design. This article is a critical reflection on some of the objections made to randomized clinical trials, evaluating how and to what extent these trials could be configured as a valid scientific research strategy in this critical context. We concluded that the RCT should be used - as long as it is performed in a critical context - due to its pragmatic value, as a producer of predictions and interventions capable of solving clinical problems, inevitably defined and established from the particular point of view of a community.

Résumé L'essai clinique randomisé est considéré comme le type de conception méthodologique ayant le plus puissant pour vérifier l'efficacité des psychothérapies. Cependant, surtout depuis la seconde moitié du XXe siècle, de nombreuses critiques adressées aux conceptions épistémologiques qui sous-tendent les sciences dites « dures ¼ ont également affecté, dans le cadre des sciences de la santé, les études qui ont adopté cette conception. Cet article est une réflexion critique sur certaines des objections faites aux essais cliniques randomisés, évaluant comment et dans quelle mesure ceux-ci pourraient être configurés comme une stratégie valide de recherche scientifique dans le contexte critique signalé. On en conclu que l'ECA peut et doit être utilisé - à condition que ce soit dans un contexte critique - pour sa valeur pragmatique, en tant que producteur de prédictions et d'interventions capables de résoudre des problèmes cliniques, inévitablement définies et établies du point de vue particulier d'une communauté.

Resumen El ensayo clínico aleatorizado (ECA) se considera el tipo de diseño metodológico con mayor poder para verificar la eficacia de las psicoterapias. Sin embargo, especialmente desde la segunda mitad del siglo XX, muchas críticas dirigidas a las concepciones epistemológicas subyacentes a las llamadas "ciencias duras" también han afectado, dentro del alcance de las ciencias de la salud, los estudios que adoptan este diseño. Este artículo es una reflexión crítica sobre algunas de las objeciones hechas a los ECA, evaluando cómo y en qué medida podrían configurarse como una estrategia de investigación científica válida en este contexto crítico. Se concluye que el ECA puede y debe usarse, siempre y cuando se encuentre en un contexto crítico, por su valor pragmático como productor de predicciones e intervenciones capaces de resolver los problemas clínicos inevitablemente definidos y establecidos desde el punto de vista particular de una comunidade.

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