A multi-centre, double-blind, 12-week, randomized, placebo-controlled trial to assess the efficacy of adjunctive N-Acetylcysteine for treatment-resistant PTSD: a study protocol

Self-regulation, the regulation of behaviour in early childhood, impacts children’s success at school and is a predictor of health, wealth, and criminal outcomes in adulthood. Self-regulation may be optimised by dietary supplementation of omega-3 long-chain polyunsaturated fatty acids (n-3 LCPUFAs). The aim of the “Omega Kid” study is to investigate the feasibility of a protocol to investigate whether n-3 LCPUFA supplementation enhances self-regulation in preschool-aged children. The protocol assessed involved a double-blind, randomised, placebo-controlled trial of 12 weeks duration, with an intervention of 1.6 g of eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) per day (0.3 g EPA and 1.3 g DHA) in a microencapsulated powder compared to placebo. Children (n = 78; 40 boys and 38 girls) aged 3–5 years old were recruited and randomly allocated to the treatment (n = 39) or placebo group (n = 39). The HS–Omega-3 Index® served as a manipulation check on the delivery of either active (n-3 LCPUFAs) or placebo powders. Fifty-eight children (76%) completed the intervention (28–30 per group). Compliance to the study protocol was high, with 92% of children providing a finger-prick blood sample at baseline and high reported-adherence to the study intervention (88%). Results indicate that the protocol is feasible and may be employed in an adequately powered clinical trial to test the hypothesis that n-3 LCPUFA supplementation will improve the self-regulation of preschool-aged children.

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The PSSMAR study. Postacute sarcopenia: Supplementation with β-hydroxyMethylbutyrate after resistance training: Study protocol of a randomized, double-blind controlled trial

Maturitas ◽

10.1016/j.maturitas.2016.08.019 ◽

2016 ◽

Vol 94 ◽

pp. 117-124 ◽

Cited By ~ 3

Author(s):

Dolores Sánchez-Rodríguez ◽

Ester Marco ◽

Natalia Ronquillo-Moreno ◽

Ramón Miralles ◽

Sergi Mojal ◽

...

Keyword(s):

Resistance Training ◽

Study Protocol ◽

Controlled Trial ◽

Double Blind ◽

Training Study

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A randomised, double-blind, placebo-controlled trial of minocycline and/or omega-3 fatty acids added to treatment as usual for at-risk mental states (NAYAB): study protocol

Trials ◽

10.1186/s13063-017-2275-y ◽

2017 ◽

Vol 18 (1) ◽

Cited By ~ 7

Author(s):

Inti Qurashi ◽

Imran B. Chaudhry ◽

Ameer B. Khoso ◽

Sana Farooque ◽

Steve Lane ◽

...

Keyword(s):

Fatty Acids ◽

Study Protocol ◽

Controlled Trial ◽

Mental States ◽

Omega 3 Fatty Acids ◽

Omega 3 ◽

Double Blind ◽

Treatment As Usual ◽

Double Blind Placebo ◽

At Risk Mental States

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Study protocol: a double blind placebo controlled trial examining the effect of domperidone on the composition of breast milk [NCT00308334]

BMC Pregnancy and Childbirth ◽

10.1186/1471-2393-6-17 ◽

2006 ◽

Vol 6 (1) ◽

Cited By ~ 4

Author(s):

Marsha L Campbell-Yeo ◽

Alexander C Allen ◽

K S Joseph ◽

Joyce M Ledwidge ◽

Victoria M Allen ◽

...

Keyword(s):

Breast Milk ◽

Study Protocol ◽

Controlled Trial ◽

Double Blind ◽

Double Blind Placebo

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Left prefrontal transcranial magnetic stimulation for treatment-resistant depression in adolescents: a double-blind, randomized, sham-controlled trial

Neuropsychopharmacology ◽

10.1038/s41386-020-00829-y ◽

2020 ◽

Vol 46 (2) ◽

pp. 462-469

Author(s):

Paul E. Croarkin ◽

Ahmed Z. Elmaadawi ◽

Scott T. Aaronson ◽

G. Randolph Schrodt ◽

Richard C. Holbert ◽

...

Keyword(s):

Transcranial Magnetic Stimulation ◽

Magnetic Stimulation ◽

Controlled Trial ◽

Treatment Resistant Depression ◽

Treatment Resistant ◽

Double Blind ◽

Resistant Depression

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Rapid antidepressant effects of the psychedelic ayahuasca in treatment-resistant depression: a randomized placebo-controlled trial

Psychological Medicine ◽

10.1017/s0033291718001356 ◽

2018 ◽

Vol 49 (4) ◽

pp. 655-663 ◽

Cited By ~ 92

Author(s):

Fernanda Palhano-Fontes ◽

Dayanna Barreto ◽

Heloisa Onias ◽

Katia C. Andrade ◽

Morgana M. Novaes ◽

...

Keyword(s):

Rating Scale ◽

Remission Rate ◽

Controlled Trial ◽

Treatment Resistant Depression ◽

Treatment Resistant ◽

Open Label ◽

Double Blind ◽

Therapeutic Value ◽

Antidepressant Effects ◽

Resistant Depression

AbstractBackgroundRecent open-label trials show that psychedelics, such as ayahuasca, hold promise as fast-onset antidepressants in treatment-resistant depression.MethodsTo test the antidepressant effects of ayahuasca, we conducted a parallel-arm, double-blind randomized placebo-controlled trial in 29 patients with treatment-resistant depression. Patients received a single dose of either ayahuasca or placebo. We assessed changes in depression severity with the Montgomery-Åsberg Depression Rating Scale (MADRS) and the Hamilton Depression Rating scale at baseline, and at 1 (D1), 2 (D2), and 7 (D7) days after dosing.ResultsWe observed significant antidepressant effects of ayahuasca when compared with placebo at all-time points. MADRS scores were significantly lower in the ayahuasca group compared with placebo at D1 and D2 (p= 0.04), and at D7 (p< 0.0001). Between-group effect sizes increased from D1 to D7 (D1: Cohen'sd= 0.84; D2: Cohen'sd= 0.84; D7: Cohen'sd= 1.49). Response rates were high for both groups at D1 and D2, and significantly higher in the ayahuasca group at D7 (64%v.27%;p= 0.04). Remission rate showed a trend toward significance at D7 (36%v.7%,p= 0.054).ConclusionsTo our knowledge, this is the first controlled trial to test a psychedelic substance in treatment-resistant depression. Overall, this study brings new evidence supporting the safety and therapeutic value of ayahuasca, dosed within an appropriate setting, to help treat depression. This study is registered athttp://clinicaltrials.gov(NCT02914769).

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