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Double-blind fluoxetine trial in comorbid MDD-CUD youth and young adults.

ABSTRACT: OBJECTIVE:This study compared the acute phase (12-week) efficacy of fluoxetine versus placebo for the treatment of the depressive symptoms and the cannabis use of adolescents and young adults with comorbid major depression (MDD) and a cannabis use disorder (CUD) (cannabis dependence or cannabis abuse). We hypothesized that fluoxetine would demonstrate efficacy versus placebo for the treatment of the depressive symptoms and the cannabis use of adolescents and young adults with comorbid MDD/CUD. METHODS:We conducted the first double-blind placebo-controlled study of fluoxetine in adolescents and young adults with comorbid MDD/CUD. All participants in both treatment groups also received manual-based cognitive behavioral therapy (CBT) and motivation enhancement therapy (MET) during the 12-week course of the study. RESULTS:Fluoxetine was well tolerated in this treatment population. No significant group-by-time interactions were noted for any depression-related or cannabis-use related outcome variable over the 12-week study. Subjects in both the fluoxetine group and the placebo group showed significant within-group improvement in depressive symptoms and in number of DSM diagnostic criteria for a CUD. Large magnitude decreases in depressive symptoms were noted in both treatment groups, and end-of-study levels of depressive symptoms were low in both treatment groups. CONCLUSIONS:Fluoxetine did not demonstrate greater efficacy than placebo for treating either the depressive symptoms or the cannabis-related symptoms of our study sample of comorbid adolescents and young adults. The lack of a significant between-group difference in these symptoms may reflect limited medication efficacy, or may result from efficacy of the CBT/MET psychotherapy or from limited sample size.

SUBMITTER: Cornelius JR

PROVIDER: S-EPMC2946416 | biostudies-literature | 2010 Nov

REPOSITORIES: biostudies-literature

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Double-blind fluoxetine trial in comorbid MDD-CUD youth and young adults.

Cornelius Jack R JR Bukstein Oscar G OG Douaihy Antoine B AB Clark Duncan B DB Chung Tammy A TA Daley Dennis C DC Wood D Scott DS Brown Sandra J SJ

Drug and alcohol dependence 20100623 1-2

<h4>Objective</h4>This study compared the acute phase (12-week) efficacy of fluoxetine versus placebo for the treatment of the depressive symptoms and the cannabis use of adolescents and young adults with comorbid major depression (MDD) and a cannabis use disorder (CUD) (cannabis dependence or cannabis abuse). We hypothesized that fluoxetine would demonstrate efficacy versus placebo for the treatment of the depressive symptoms and the cannabis use of adolescents and young adults with comorbid MD ...[more]

PMID: 20576364

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Project description:BACKGROUND:Non-nutritive sweeteners (NNS) are widely consumed by humans due to their apparent innocuity, especially sucralose. However, several studies link sucralose consumption to weight gain and metabolic derangements, although data are still contradictory. OBJECTIVE:To determine the effect of acute and chronic consumption of sucralose on insulin and glucose profiles in young healthy adults. MATERIAL AND METHODS:This was a randomized, parallel, double-blind, placebo-controlled trial conducted in healthy young adults from 18 to 35?years old, without insulin resistance. A hundred thirty seven participants were randomized into three groups: a) volunteers receiving 48?mg sucralose, b) volunteers receiving 96?mg sucralose, and c) controls receiving water as placebo. All participants underwent a 3-h oral glucose tolerance test (OGTT) preceded by consuming sucralose or placebo 15?min before glucose load, at two time points: week zero (Wk0) and week ten (Wk10). Serum insulin and glucose were measured every 15?min during both OGTTs. RESULTS:Compared to Wk0, consumption of sucralose for 10?weeks provoked 1) increased insulin concentrations at 0?min (7.5?±?3.4 vs 8.8?±?4.1 ?IU/mL; p?=?0.01), 30?min (91.3?±?56.2 vs 110.1?±?49.4 ?IU/mL; p?=?0.05), 105?min (47.7?±?24.4 vs 64.3?±?48.2 ?IU/mL; p?=?0.04) and 120?min (44.8?±?22.1 vs 63.1?±?47.8 ?IU/mL; p?=?0.01) in the 48?mg sucralose group; 2) increased blood glucose at -?15?min (87.9?±?4.6 vs 91.4?±?5.4?mg/dL; p?=?0.003), 0?min (88.7?±?4 vs 91.3?±?6?mg/dL; p?=?0.04) and 120?min (95.2?±?23.7 vs 106.9?±?19.5?mg/dL; p?=?0.009) in the 48?mg sucralose group; 3) increased area under the curve (AUC) of insulin in both 48 and 96?mg sucralose groups (9262 vs 11,398; p?=?0.02 and 6962 vs 8394; p?=?0.12, respectively); and 4) reduced Matsuda index in the 48?mg sucralose group (6.04?±?3.19 vs 4.86?±?2.13; p?=?0.01). CONCLUSIONS:These data show that chronic consumption of sucralose can affect insulin and glucose responses in non-insulin resistant healthy young adults with normal body mass index (between 18.5 and 24.9?kg/m2), however, the effects are not consistent with dose; further research is required. CLINICAL TRIAL REGISTRY:NCT03703141.

Project description:BackgroundResults of small trials indicate that fluoxetine might improve functional outcomes after stroke. The FOCUS trial aimed to provide a precise estimate of these effects.MethodsFOCUS was a pragmatic, multicentre, parallel group, double-blind, randomised, placebo-controlled trial done at 103 hospitals in the UK. Patients were eligible if they were aged 18 years or older, had a clinical stroke diagnosis, were enrolled and randomly assigned between 2 days and 15 days after onset, and had focal neurological deficits. Patients were randomly allocated fluoxetine 20 mg or matching placebo orally once daily for 6 months via a web-based system by use of a minimisation algorithm. The primary outcome was functional status, measured with the modified Rankin Scale (mRS), at 6 months. Patients, carers, health-care staff, and the trial team were masked to treatment allocation. Functional status was assessed at 6 months and 12 months after randomisation. Patients were analysed according to their treatment allocation. This trial is registered with the ISRCTN registry, number ISRCTN83290762.FindingsBetween Sept 10, 2012, and March 31, 2017, 3127 patients were recruited. 1564 patients were allocated fluoxetine and 1563 allocated placebo. mRS data at 6 months were available for 1553 (99·3%) patients in each treatment group. The distribution across mRS categories at 6 months was similar in the fluoxetine and placebo groups (common odds ratio adjusted for minimisation variables 0·951 [95% CI 0·839-1·079]; p=0·439). Patients allocated fluoxetine were less likely than those allocated placebo to develop new depression by 6 months (210 [13·43%] patients vs 269 [17·21%]; difference 3·78% [95% CI 1·26-6·30]; p=0·0033), but they had more bone fractures (45 [2·88%] vs 23 [1·47%]; difference 1·41% [95% CI 0·38-2·43]; p=0·0070). There were no significant differences in any other event at 6 or 12 months.InterpretationFluoxetine 20 mg given daily for 6 months after acute stroke does not seem to improve functional outcomes. Although the treatment reduced the occurrence of depression, it increased the frequency of bone fractures. These results do not support the routine use of fluoxetine either for the prevention of post-stroke depression or to promote recovery of function.FundingUK Stroke Association and NIHR Health Technology Assessment Programme.

Project description:During leisure activities young people are often exposed to excessive noise levels resulting in an increase of noise-induced symptoms such as hearing loss, tinnitus and hyperacusis. Noise-induced tinnitus is often perceived after loud music exposure and provides an important marker for overexposure as a temporary threshold shift that is often not experienced by the individual itself. As oxidative stress plays an important role in the pathogenesis of noise-induced hearing loss, the use of antioxidants to prevent hearing damage has recently become the subject of research.This study proposes a randomized, double-blind, placebo-controlled crossover trial to assess the effects of a prophylactic combination of N-acetylcysteine (600 mg) and magnesium (200 mg) prior to leisure noise exposure in young adults. The primary outcome measure is the tinnitus loudness scored by a visual analogue scale (VAS). Secondary outcome measures are the differences in audiological measurements for the antioxidant treatments compared to placebo intake. Audiological testing comprising of pure tone audiometry including frequencies up to 16 kHz, distortion product otoacoustic emissions, transient-evoked otoacoustic emissions and speech-in-noise testing will be performed prior to and within 7 hours after noise exposure. By use of a mixed effects statistical model, the effects of antioxidants compared to placebo intake will be assessed.As adolescents and young adults often do not use hearing protection while being exposed to loud music, the use of preventive antioxidant intake may provide a useful and harmless way to prevent noise-induced hearing damage in this population. Furthermore, when exposed to hazardous noise levels the protection provided by hearing protectors might not be sufficient to prevent hearing damage and antioxidants may provide additive otoprotective effects. Previous research mainly focused on occupational noise exposure. The present study provides a protocol to assess the usefulness of antioxidants during leisure noise activities.The present protocol is registered at ClinicalTrials.gov: NCT01727492.

Dataset Information

Double-blind fluoxetine trial in comorbid MDD-CUD youth and young adults.

Publications

Double-blind fluoxetine trial in comorbid MDD-CUD youth and young adults.

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