Escitalopram and Neuroendocrine Response in Healthy First-Degree Relatives to Depressed Patients – A Randomized Placebo-Controlled Trial

Two double-blind four-way crossover studies are reported, comparing the antidepressant effect of 14-day courses of: viloxazine, viloxazine with a tranquillizer either perphenazine or diazepam or tranquillizer alone, against a placebo. In one study the antidepressant effect of viloxazine at a dose of 150 mg daily was statistically greater than that of placebo, whilst in the second study viloxazine was statistically superior to diazepam (15 mg daily). In depressed patients with a clear anxiety component, viloxazine alone seemed preferable to a combination with a tranquillizer as such a combination did not produce an enhanced clinical effect and the incidence of side-effects was possibly increased. Viloxazine was generally well tolerated and side-effects, when they occurred, were generally a mild upper gastro-intestinal disturbance.

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Depressed patients treated by homeopaths: a protocol for a pragmatic randomized controlled trial and qualitative study applying the cmRCT design

Homeopathy ◽

10.1016/j.homp.2013.10.065 ◽

2014 ◽

Vol 103 (1) ◽

pp. 93

Author(s):

P. Viksveen ◽

C. Relton ◽

P. Bissell

Keyword(s):

Randomized Controlled Trial ◽

Qualitative Study ◽

Controlled Trial ◽

Pragmatic Randomized Controlled Trial ◽

Randomized Controlled ◽

Depressed Patients

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Facilitated cascade testing (FaCT): a randomized controlled trial

International Journal of Gynecological Cancer ◽

10.1136/ijgc-2020-002118 ◽

2020 ◽

pp. ijgc-2020-002118

Author(s):

Roni Nitecki ◽

Haley A Moss ◽

Catherine H Watson ◽

Diana L Urbauer ◽

Alexander Melamed ◽

...

Keyword(s):

Genetic Testing ◽

Controlled Trial ◽

Randomized Study ◽

Standard Of Care ◽

Pathogenic Mutation ◽

Primary Objective ◽

Care Group ◽

Patient Navigator ◽

Cascade Testing ◽

First Degree Relatives

BackgroundIdentifying mutation-carrying relatives of patients with hereditary cancer syndromes via cascade testing is an underused first step in primary cancer prevention. A feasibility study of facilitated genetic testing of at-risk relatives of patients with a known pathogenic mutation demonstrated encouraging uptake of cascade testing.Primary objectiveOur primary objective is to compare the proportion of genetic testing of identified first-degree relatives of probands with a confirmed BRCA1/2 mutation randomized to a facilitated cascade testing strategy versus standard of care, proband-mediated, information sharing.Study hypothesisWe hypothesize that facilitated cascade testing will drive significantly higher uptake of genetic testing than the standard of care.Trial designThe FaCT (Facilitated Cascade Testing) trial is a prospective multi-institutional randomized study comparing the efficacy of a multicomponent facilitated cascade testing intervention with the standard of care. Patients with a known BRCA1/2 mutation (probands) cared for at participating sites will be randomized. Probands randomized to the standard of care group will be instructed to share a family letter with their first-degree relatives and encourage them to complete genetic testing. First-degree relatives of probands randomized to the intervention arm will receive engagement strategies with a patient navigator, an educational video, and accessible genetic testing services.Major inclusion/exclusion criteriaAdult participants who are first-degree relatives of a patient with a BRCA1/2 mutation and have not had prior genetic testing will be included.Primary endpointAnalyses will assess the proportion of first-degree relatives identified by the proband who complete genetic testing by 6 months in the intervention arm versus the control arm.Sample sizeOne hundred and fifty probands with a BRCA1/2 mutation will be randomized. Each proband is expected to provide an average of 3 relatives, for an expected 450 participants.Estimated dates for completing accrual and presenting resultsJanuary 2024.Trial registrationNCT04613440

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A pilot randomised controlled trial of personalised care for depressed patients with symptomatic coronary heart disease in South London general practices: the UPBEAT-UK RCT protocol and recruitment

BMC Psychiatry ◽

10.1186/1471-244x-12-58 ◽

2012 ◽

Vol 12 (1) ◽

Cited By ~ 7

Author(s):

André Tylee ◽

Mark Haddad ◽

Elizabeth Barley ◽

Mark Ashworth ◽

June Brown ◽

...

Keyword(s):

Coronary Heart Disease ◽

Heart Disease ◽

Randomised Controlled Trial ◽

Controlled Trial ◽

Pilot Randomised Controlled Trial ◽

Depressed Patients ◽

General Practices ◽

Randomised Controlled

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Effects of recombinant human erythropoietin on cognition and neural activity in remitted patients with mood disorders and first-degree relatives of patients with psychiatric disorders: a study protocol for a randomized controlled trial

Trials ◽

10.1186/s13063-018-2995-7 ◽

2018 ◽

Vol 19 (1) ◽

Cited By ~ 3

Author(s):

Jeff Zarp Petersen ◽

Lejla Sjanic Schmidt ◽

Maj Vinberg ◽

Martin Balslev Jørgensen ◽

Ida Hageman ◽

...

Keyword(s):

Randomized Controlled Trial ◽

Psychiatric Disorders ◽

Mood Disorders ◽

Study Protocol ◽

Neural Activity ◽

Recombinant Human Erythropoietin ◽

Controlled Trial ◽

Randomized Controlled ◽

First Degree Relatives ◽

Human Erythropoietin

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Outcome of Psychoanalytic and Cognitive-Behavioural Long-Term Therapy with Chronically Depressed Patients: A Controlled Trial with Preferential and Randomized Allocation

The Canadian Journal of Psychiatry ◽

10.1177/0706743718780340 ◽

2018 ◽

Vol 64 (1) ◽

pp. 47-58 ◽

Cited By ~ 17

Author(s):

Marianne Leuzinger-Bohleber ◽

Martin Hautzinger ◽

Georg Fiedler ◽

Wolfram Keller ◽

Ulrich Bahrke ◽

...

Keyword(s):

Depressive Symptoms ◽

Multilevel Models ◽

Controlled Trial ◽

Behavioural Therapy ◽

Effect Sizes ◽

Term Therapy ◽

Depressed Patients ◽

Cognitive Behavioural ◽

Remission Rates

Objective: For chronic depression, the effectiveness of brief psychotherapy has been limited. This study is the first comparing the effectiveness of long-term cognitive-behavioural therapy (CBT) and long-term psychoanalytic therapy (PAT) of chronically depressed patients and the effects of preferential or randomized allocation. Methods: A total of 252 adults met the inclusion criteria (aged 21-60 years, major depression, dysthymia, double depression for at least 24 months, Quick Inventory of Depressive Symptoms [QIDS] >9, Beck Depression Inventory II [BDI] >17, informed consent, not meeting exclusion criteria). Main outcome measures were depression self-rating (BDI) and rating (clinician-rated QIDS [QIDS-C]) by independent, treatment-blinded clinicians. Full remission rates (BDI ≤12, QIDS-C ≤5) were calculated. An independent center for data management and biostatistics analyzed the treatment effects and differences using linear mixed models (multilevel models and hierarchical models). Results: The average BDI declined from 32.1 points by 12.1 points over the first year and 17.2 points over 3 years. BDI overall mean effect sizes increased from d = 1.17 after 1 year to d = 1.83 after 3 years. BDI remission rates increased from 34% after 1 year to 45% after 3 years. QIDS-C overall effect sizes increased from d = 1.56 to d = 2.08, and remission rates rose from 39% after 1 year to 61% after 3 years. We found no significant differences between PAT and CBT or between preferential and randomized allocation. Conclusions: Psychoanalytic as well as cognitive-behavioural long-term treatments lead to significant and sustained improvements of depressive symptoms of chronically depressed patients exceeding effect sizes of other international outcome studies.

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Vitamin B12 Supplementation in Treating Major Depressive Disorder: A Randomized Controlled Trial

The Open Neurology Journal ◽

10.2174/1874205x01307010044 ◽

2013 ◽

Vol 7 (1) ◽

pp. 44-48 ◽

Cited By ~ 22

Author(s):

Ehsan Ullah Syed ◽

Mohammad Wasay ◽

Safia Awan

Keyword(s):

Treatment Group ◽

Vitamin B12 ◽

Controlled Trial ◽

Vitamin B12 Deficiency ◽

Major Depressive ◽

Randomized Controlled ◽

Depressed Patients ◽

B12 Deficiency ◽

Vitamin B12 Supplementation

Background/Objective: Recent literature has identified links between vitamin B12 deficiency and depression.We compared the clinical response of SSRI-monotherapy with that of B12-augmentation in a sample of depressed patients with low normal B12 levels who responded inadequately to the first trial with the SSRIs. Methods: Patients with depression and low normal B12 levels were randomized to a control arm (antidepressant only) or treatment arm (antidepressants and injectable vitamin B12 supplementation). Results: A total of 199 depressed patients were screened. Out of 73 patients with low normal B12 levels 34 (47%) were randomized to the treatment group while 39 (53%) were randomized to the control arm. At three months follow up 100% of the treatment group showed at least a 20% reduction in HAM-D score, while only 69% in the control arm showed at least a 20% reduction in HAM-D score (p<0.001). The findings remained significant after adjusting for baseline HAM-D score (p=0.001). Conclusion: Vitamin B12 supplementation with antidepressants significantly improved depressive symptoms in our cohort.

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