A Double-Blind, Randomized, Placebo-Controlled Study of Quetiapine as Adjunctive Treatment for Adolescent Mania

BackgroundEpidemiological and clinical studies suggest that increased intake of eicosapentaenoic acid (EPA) alleviates unipolar depression.AimsTo examine the efficacy of EPA in treating depression in bipolar disorder.MethodIn a 12-week, double-blind study individuals with bipolar depression were randomly assigned to adjunctive treatment with placebo (n=26) or with 1g/day (n=24) or 2 g/day (n=25) of ethyl-EPA. Primary efficacy was assessed by the Hamilton Rating Scale for Depression (HRSD), with changes in the Young Mania Rating Scale and Clinical Global Impression Scale (CGI) as secondary outcome measures.ResultsThere was no apparent benefit of 2g over 1g ethyl-EPA daily. Significant improvement was noted with ethyl-EPA treatment compared with placebo in the HRSD (P=0.04) and the CGI (P=0.004) scores. Both doses were well tolerated.ConclusionsAdjunctive ethyl-EPA is an effective and well-tolerated intervention in bipolar depression.

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A double-blind, placebo-controlled study of edivoxetine as an adjunctive treatment for patients with major depressive disorder who are partial responders to selective serotonin reuptake inhibitor treatment

Journal of Affective Disorders ◽

10.1016/j.jad.2014.06.006 ◽

2014 ◽

Vol 167 ◽

pp. 215-223 ◽

Cited By ~ 9

Author(s):

Susan Ball ◽

Mary Anne Dellva ◽

Deborah N. D'Souza ◽

Lauren B. Marangell ◽

James M. Russell ◽

...

Keyword(s):

Major Depressive Disorder ◽

Depressive Disorder ◽

Selective Serotonin Reuptake Inhibitor ◽

Serotonin Reuptake ◽

Adjunctive Treatment ◽

Controlled Study ◽

Major Depressive ◽

Double Blind ◽

Double Blind Placebo ◽

Inhibitor Treatment

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Efficacy and safety of TS-121, a novel vasopressin V1B receptor antagonist, as adjunctive treatment for patients with major depressive disorder: A randomized, double-blind, placebo-controlled study

Journal of Psychiatric Research ◽

10.1016/j.jpsychires.2020.05.017 ◽

2020 ◽

Vol 128 ◽

pp. 43-51

Author(s):

Makoto Kamiya ◽

Helene D. Sabia ◽

Julie Marella ◽

Maurizio Fava ◽

Charles B. Nemeroff ◽

...

Keyword(s):

Major Depressive Disorder ◽

Depressive Disorder ◽

Receptor Antagonist ◽

Adjunctive Treatment ◽

Controlled Study ◽

Efficacy And Safety ◽

Major Depressive ◽

Double Blind ◽

Double Blind Placebo ◽

V1b Receptor

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Randomized phase 2 study of adjunctive cenobamate in patients with uncontrolled focal seizures

Neurology ◽

10.1212/wnl.0000000000009530 ◽

2020 ◽

Vol 94 (22) ◽

pp. e2311-e2322 ◽

Cited By ~ 11

Author(s):

Steve S. Chung ◽

Jacqueline A. French ◽

Jacek Kowalski ◽

Gregory L. Krauss ◽

Sang Kun Lee ◽

...

Keyword(s):

Seizure Frequency ◽

Maintenance Phase ◽

Baseline Period ◽

Adjunctive Treatment ◽

Controlled Study ◽

Double Blind ◽

Focal Seizures ◽

Free Treatment ◽

Titration Phase ◽

Motor Component

ObjectiveTo evaluate the efficacy and safety of adjunctive cenobamate 200 mg/d in patients with uncontrolled focal (partial-onset) seizures despite treatment with 1 to 3 antiepileptic drugs.MethodsIn this multicenter, double-blind, placebo-controlled study, adults 18 to 65 years of age with focal seizures were randomized 1:1 (cenobamate:placebo) after an 8-week baseline period. The 12-week double-blind treatment period consisted of a 6-week titration phase and a 6-week maintenance phase. The primary outcome was percent change in seizure frequency (from baseline) per 28 days during double-blind treatment.ResultsTwo hundred twenty-two patients were randomized; 113 received cenobamate and 109 received placebo; and 90.3% and 90.8% of patients, respectively, completed double-blind treatment. Median baseline seizure frequency was 6.5 in 28 days (range 0–237). Compared to placebo, cenobamate conferred a greater median percent seizure reduction (55.6% vs 21.5%; p < 0.0001) The responder rate (≥50% reduction in seizure frequency) was 50.4% for cenobamate and 22.2% for placebo (p < 0.0001). Focal seizures with motor component, impaired awareness, and focal to bilateral tonic-clonic seizures were significantly reduced with cenobamate vs placebo. During maintenance, 28.3% of cenobamate-treated and 8.8% of placebo-treated patients were seizure-free. Treatment-emergent adverse events reported in >10% in either group (cenobamate vs placebo) were somnolence (22.1% vs 11.9%), dizziness (22.1% vs 16.5%), headache (12.4% vs 12.8%), nausea (11.5% vs 4.6%), and fatigue (10.6% vs 6.4%).ConclusionAdjunctive treatment with cenobamate 200 mg/d significantly improved seizure control in adults with uncontrolled focal seizures and was well tolerated.ClinicalTrials.gov identifierNCT01397968.Classification of evidenceThis study provides Class I evidence that, for patients with uncontrolled focal seizures, adjunctive cenobamate reduces seizures.

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Efficacy of Multivitamin Supplementation Containing Vitamins B6 and B12 and Folic Acid as Adjunctive Treatment with a Cholinesterase Inhibitor in Alzheimer's Disease: A 26-Week, Randomized, Double-Blind, Placebo-Controlled Study in Taiwanese Patients

Clinical Therapeutics ◽

10.1016/j.clinthera.2007.10.012 ◽

2007 ◽

Vol 29 (10) ◽

pp. 2204-2214 ◽

Cited By ~ 56

Author(s):

Yu Sun ◽

Chien-Jung Lu ◽

Kuo-Liong Chien ◽

Sien-Tsong Chen ◽

Rong-Chi Chen

Keyword(s):

Alzheimer’S Disease ◽

Alzheimer's Disease ◽

Folic Acid ◽

Cholinesterase Inhibitor ◽

Adjunctive Treatment ◽

Controlled Study ◽

Double Blind ◽

Multivitamin Supplementation ◽

Double Blind Placebo

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P03-30 - Adjunctive treatment with naltrexone in patients with schizophrenia and substance use disorder: a double-blind, placebo-controlled study

European Psychiatry ◽

10.1016/s0924-9338(10)71140-8 ◽

2010 ◽

Vol 25 ◽

pp. 1151

Author(s):

J. Berman ◽

R. Savu ◽

I. Berman

Keyword(s):

Substance Use ◽

Substance Use Disorder ◽

Adjunctive Treatment ◽

Controlled Study ◽

Double Blind ◽

Double Blind Placebo

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Memantine as adjunctive treatment to risperidone in children with autistic disorder: a randomized, double-blind, placebo-controlled trial

The International Journal of Neuropsychopharmacology ◽

10.1017/s1461145712000880 ◽

2013 ◽

Vol 16 (4) ◽

pp. 783-789 ◽

Cited By ~ 48

Author(s):

Ali Ghaleiha ◽

Mahtab Asadabadi ◽

Mohammad-Reza Mohammadi ◽

Maryam Shahei ◽

Mina Tabrizi ◽

...

Keyword(s):

Side Effects ◽

Controlled Trial ◽

Neurodevelopmental Disorder ◽

Children With Autism ◽

Primary Outcome Measure ◽

Adjunctive Treatment ◽

Controlled Study ◽

Double Blind ◽

Aberrant Behavior Checklist ◽

Double Blind Placebo

Abstract Autism is a neurodevelopmental disorder that causes significant impairment in socialization and communication. It is also associated with ritualistic and stereotypical behaviour. Recent studies propose both hyper-and hypoglutamatergic ideologies for autism. The objective of this study was to assess the effects of memantine plus risperidone in the treatment of children with autism. Children with autism were randomly allocated to risperidone plus memantine or placebo plus risperidone for a 10-wk, double-blind, placebo-controlled study. The dose of risperidone was titrated up to 3 mg/d and memantine was titrated to 20 mg/d. Children were assessed at baseline and after 2, 4, 6, 8 and 10 wk of starting medication protocol. The primary outcome measure was the irritability subscale of Aberrant Behavior Checklist–Community (ABC-C). Difference between the two treatment arms was significant as the group that received memantine had greater reduction in ABC-C subscale scores for irritability, stereotypic behaviour and hyperactivity. Eight side-effects were observed over the trial, out of the 25 side-effects that the checklist included. The difference between the two groups in the frequency of side-effects was not significant. The present study suggests that memantine may be a potential adjunctive treatment strategy for autism and it was generally well tolerated. This trial is registered with the Iranian Clinical Trials Registry (IRCT1138901151556N10; www.irct.ir)

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Adjunctive aripiprazole in risperidone-induced hyperprolactinaemia: double-blind, randomised, placebo-controlled trial

BJPsych Open ◽

10.1192/bjpo.bp.115.001248 ◽

2015 ◽

Vol 1 (2) ◽

pp. 172-177 ◽

Cited By ~ 13

Author(s):

G. Raghuthaman ◽

R. Venkateswaran ◽

R. Krishnadas

Keyword(s):

Side Effects ◽

Controlled Trial ◽

Adjunctive Treatment ◽

Serum Prolactin ◽

Controlled Study ◽

Number Needed To Treat ◽

Double Blind ◽

Sexual Side Effects ◽

Second Generation Antipsychotics ◽

Effect Of Treatment

BackgroundHyperprolactinaemia is a troublesome side-effect of treatment with antipsychotics.AimsThis double-blind, placebo-controlled study aimed at examining the effect of adjunctive treatment with 10 mg aripiprazole on prolactin levels and sexual side-effects in patients with schizophrenia symptomatically maintained on risperidone.MethodThirty patients taking risperidone were enrolled into the trial (CTRI/2012/11/003114). Aripiprazole was administered at a fixed daily dose of 10 mg/day for 8 weeks. Serum prolactin was measured at baseline and at 8 weeks. Hyperprolactinaemia-related problems, psychopathology and side-effects were evaluated every 2 weeks.ResultsProlactin levels decreased by 58% in the aripiprazole group compared with an increase by 22% in the placebo group. Prolactin levels normalised in 46% of patients in the aripiprazole group (number needed to treat, NNT=2). Aripiprazole improved erectile dysfunction in five out of six patients. There were no significant differences in change in psychopathology or side-effects between groups.ConclusionsAdjunctive aripiprazole reduced prolactin levels in those treated with risperidone, with no effect on psychopathology and extrapyramidal symptoms. This is a potential treatment for hyperprolactinaemia observed during treatment with second-generation antipsychotics.

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