Adjunctive sapropterin dihydrochloride treatment in schizophrenia: A positive proof-of-concept, rater-blind, randomized, multivitamin-controlled study

Based on the emerging interest in the effects of gut microbiota on cognition, this proof-of-concept study assessed how children aged 7 to 9 with low reading scores responded to the ingestion of a 3-month prebiotic supplement versus a placebo. As a secondary aim, the effects of the prebiotic on cognition, sleep, behaviour, mood, anxiety, and cortisol were assessed. In this sample, the prebiotic did not affect any of the outcome measures.

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Tu1846 PHASE 2A PROOF OF CONCEPT PLACEBO CONTROLLED STUDY WITH ORAL ABX464 50MG QD IN ULCERATIVE COLITIS SHOWS ENDOSCOPIC IMPROVEMENT WITH LOSS OF MICROSCOPIC DISEASE ACTIVITY IN MOST ENDOSCOPIC RESPONDERS

Gastroenterology ◽

10.1016/s0016-5085(20)33633-7 ◽

2020 ◽

Vol 158 (6) ◽

pp. S-1185

Author(s):

Gert De Hertogh ◽

Jean-Marc Steens ◽

Julien Santo ◽

Paul Gineste ◽

Severine Vermeire

Keyword(s):

Ulcerative Colitis ◽

Disease Activity ◽

Controlled Study ◽

Proof Of Concept

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ASPREE-D: Aspirin for the prevention of depression in the elderly

International Psychogeriatrics ◽

10.1017/s104161021600079x ◽

2016 ◽

Vol 28 (10) ◽

pp. 1741-1748 ◽

Cited By ~ 10

Author(s):

Michael Berk ◽

R. L. Woods ◽

M. R. Nelson ◽

R. C. Shah ◽

C. M. Reid ◽

...

Keyword(s):

The Elderly ◽

Controlled Study ◽

Evidence Based ◽

Proof Of Concept ◽

Inflammatory Signaling ◽

Novel Therapy ◽

Definitive Evidence ◽

Randomized Controlled ◽

Anti Inflammatory

ABSTRACTBackground:Not only is depression associated with increased inflammation but inflammation is a risk factor for the genesis of depression. Many of the environmental risk factors for depression are transduced through inflammatory signaling. Anti-inflammatory agents show promise for the management of depression in preclinical, epidemiological, and early clinical studies. This opens the door to the potential for anti-inflammatory agents to treat and prevent depression. There are no evidence-based pharmacotherapies for depression prevention.Method:ASPREE-D, aspirin in the prevention of depression in the elderly, is a sub study of ASPREE, which explores the potential of aspirin to prevent a range of inflammation related disorders in the elderly. With a sample size of 19,114, and a duration of 5 years, this placebo controlled study will be one of the largest randomized controlled trials in psychiatry and will provide definitive evidence on the ability of aspirin to prevent depression.Results:This paper presents the rationale for the study and presents a summary of the study design.Conclusions:ASPREE-D may not only define novel therapy but will provide mechanistic proof of concept of the role of inflammation in depression.

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Topical application of Apremilast in the treatment of mild to moderate psoriasis

International Journal of Pharmaceutical Research and Life Sciences ◽

10.26452/ijprls.v9i1.1401 ◽

2021 ◽

Vol 9 (1) ◽

pp. 12-16

Author(s):

Srikanth Kalakoti ◽

Narasimharao Netha G

Keyword(s):

Treatment Options ◽

Controlled Study ◽

Proof Of Concept ◽

Double Blind ◽

Average Percentage ◽

Before And After ◽

Topical Dosage ◽

Associated Variety ◽

Topical Dosage Forms ◽

Topical Gels

Mild to moderate psoriasis is highly prevalent in about 80% of the global psoriatic population. Current available treatment options for mild to moderate psoriasis are topical dosage forms and are associated variety of setbacks. To address these setbacks, Apremilast topical gels, 2% & 4%, w/w were developed, and a clinical proof of concept study (POC) was performed to establish efficacy and safety. A single centre randomized, double-blind, placebo-controlled study was conducted with apremilast topical gels 2% & 4% w/w in adult mild to moderate psoriatic patients for 12 weeks. The efficacy of the gels was evaluated by comparing the PASI scores before and after treatment of 12 weeks. Both gels exhibited a significant reduction in PASI values when compared with baseline PASI scores. An average percentage inhibition of PASI with test products, i.e. 2% and 4% w/w Apremilast topical gels, are about 46.8% and 34.6%, respectively, after 12 weeks of treatment. The results confirm that the apremilast topical gels are a good option for the treatment of mild to moderate psoriasis and have to be explored further.

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