Duloxetine in the treatment of major depressive disorder: a placebo- and paroxetine-controlled trial

2006 ◽  
Vol 21 (6) ◽  
pp. 367-378 ◽  
Author(s):  
D.G.S. Perahia ◽  
F. Wang ◽  
C.H. Mallinckrodt ◽  
D.J. Walker ◽  
M.J. Detke
Keyword(s):  
Major Depressive Disorder ◽  
Depressive Disorder ◽  
Acute Phase ◽  
Rating Scale ◽  
Controlled Trial ◽  
Published Data ◽  
Efficacy And Safety ◽  
Major Depressive ◽  
Double Blind ◽  
Efficacy Measures

AbstractObjective:Duloxetine doses of 80 and 120 mg/day were assessed for efficacy and safety in the treatment of major depressive disorder (MDD).Methods:In this randomized, double-blind trial, patients age ≥ 18 meeting DSM-IV criteria for MDD were randomized to placebo (N = 99), duloxetine 80 mg/day (N = 93), duloxetine 120 mg/day (N = 103), or paroxetine 20 mg/day (N = 97). The primary outcome measure was mean change from baseline in the 17-item Hamilton rating scale for depression (HAMD17) total score after 8 weeks of treatment; a number of secondary efficacy measures also were assessed. Safety and tolerability were assessed via collection and analysis of treatment–emergent adverse events (TEAEs), vital signs, and weight. The Arizona sexual experiences scale was used to assess sexual functioning. Patients who had a ≥ 30% reduction from baseline in the HAMD17 total score at the end of the acute phase entered a 6-month continuation phase where they remained on the same treatment as they had taken during the acute phase; efficacy and safety/tolerability outcomes were assessed during continuation treatment.Results:More than 87% of patients completed the acute phase in each treatment group. Duloxetine-treated patients (both doses) showed significantly greater improvement (P < 0.05) in the HAMD17 total score at week 8 compared with placebo. Paroxetine was not significantly different from placebo (P = 0.089) on mean change on the HAMD17. Duloxetine 120 mg/day also showed significant improvement on most secondary efficacy measures (six of nine) compared with placebo while duloxetine 80 mg/day (three of nine) and paroxetine (three of nine) were significantly superior to placebo on fewer secondary measures. HAMD17 mean change data from this study and an identical sister study were pooled as defined a priori for the purposes of performing a non-inferiority test versus paroxetine. Both duloxetine doses met statistical criteria for non-inferiority to paroxetine. TEAE reporting rates were low in all treatment groups and no deaths occurred in the acute or continuation phases.Conclusions:The efficacy of duloxetine at doses of 80 and 120 mg/day in the treatment of MDD was demonstrated. Tolerability, as measured by TEAEs, and safety were similar to paroxetine 20 mg/day and consistent with previous published data on duloxetine in the treatment of MDD.

scholarly journals A randomized, double-blind, placebo-controlled 6-wk trial of the efficacy and tolerability of 5 mg vortioxetine in adults with major depressive disorder*

2012 ◽  
Vol 16 (2) ◽  
pp. 313-321 ◽  
Author(s):  
Rakesh Jain ◽  
Atul R. Mahableshwarkar ◽  
Paula L. Jacobsen ◽  
Yinzhong Chen ◽  
Michael E. Thase
Keyword(s):  
Major Depressive Disorder ◽  
Depressive Disorder ◽  
Rating Scale ◽  
P Value ◽  
Depression Symptoms ◽  
Major Depressive ◽  
Double Blind ◽  
Efficacy Measure ◽  
Efficacy Measures ◽  
Hamilton Anxiety Scale

Abstract Vortioxetine (Lu AA21004) is a multi-modal antidepressant in clinical development for the treatment of major depressive disorder (MDD). The current study evaluated the efficacy and tolerability of 5 mg vortioxetine compared to placebo after 6 wk of treatment in adults with MDD in an out-patient setting. Adults aged 18–75 yr, with a diagnosis of MDD and a baseline Montgomery–Asberg Depression Rating Scale (MADRS) total score ⩾30, were randomized to receive either 5 mg vortioxetine or placebo over 6 wk, followed by a 2-wk medication-free discontinuation period. The primary efficacy measure was change from baseline in Hamilton Rating Scale for Depression (HAMD)-24 total score at week 6 compared to placebo. Additional measures included response and remission rates, Clinical Global Impression Scale – Improvement scores, HAMD-24 total score in subjects with baseline Hamilton Anxiety Scale (HAMA) >19 and MADRS-S total score. Adverse events (AEs) were assessed throughout the study. A total of 600 adults were randomized. There were no significant differences in efficacy measures between subjects in the 5 mg vortioxetine and placebo groups at week 6. HAMD-24 total score in subjects with baseline HAMA >19 in the 5 mg vortioxetine group was improved at weeks 3–6 compared to the placebo group (nominal p value <0.05). The most common AEs for the vortioxetine and placebo groups were nausea (19.1 and 9.4%), headache (17.1 and 15.1%) and diarrhoea (11.4 and 7.0%), respectively. In this study of adults with MDD, 5 mg vortioxetine did not differ significantly from placebo in reducing depression symptoms after 6 wk of treatment.

scholarly journals The efficacy and safety of Anyu Peibo Capsule in the treatment of patients with major depressive disorder in China: study protocol for a randomized placebo-controlled trial

Trials ◽  
2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Jingjing Huang ◽  
Yimin Yu ◽  
Yi Jiang ◽  
Wu Chen ◽  
Yan Li ◽  
...  
Keyword(s):  
Major Depressive Disorder ◽  
Depressive Disorder ◽  
Rating Scale ◽  
Controlled Trial ◽  
Phase Iii ◽  
Efficacy And Safety ◽  
Phase Ii Trials ◽  
Major Depressive ◽  
Link Type ◽  
Double Blinded

Abstract Background Major depressive disorder is the second leading cause of years lost to disability worldwide. Anyu Peibo Capsule has been shown to be effective and safe in phase II trials. Methods This clinical study is a multi-center, randomized, double-blinded, placebo-controlled, parallel-group, phase III trial of Anyu Peibo Capsule in China. The aim is to test whether the administration of Anyu Peibo Capsule compared to placebo improves clinical outcomes in adults (aged 18 to 65 years) with MDD. Patients will receive an 8-week treatment of Anyu Peibo Capsule 1.6 g per day or placebo. The primary outcome will be the change from baseline in the total score for the Montgomery-Asberg Depression Rating Scale at the end of the 8-week treatment. Discussion The trial aims to provide pivotal evidence for the efficacy and safety of Anyu Peibo Capsule in patients with major depressive disorder. Trial registration ClinicalTrials.govNCT04210973. Registered on December 26, 2019

scholarly journals The efficacy and safety of Anyu Peibo Capsule in the treatment of patients with major depressive disorder in China: study protocol for a randomized placebo-controlled trial

2021 ◽  
Author(s):  
Jingjing Huang ◽  
Yimin Yu ◽  
Yi Jiang ◽  
Wu Chen ◽  
Yan Li ◽  
...  
Keyword(s):  
Major Depressive Disorder ◽  
Depressive Disorder ◽  
Rating Scale ◽  
Controlled Trial ◽  
Efficacy And Safety ◽  
Phase Ii Trials ◽  
Major Depressive ◽  
Double Blinded ◽  
Favorable Safety ◽  
Be The Change

Abstract Background: Major depressive disorder is the second leading cause of year lost to disability worldwide. Anyu Peibo Capsule was shown to have certain effective and favorable safety in phase II trials.Methods: The clinical study is a multi-center, randomized, double-blinded, placebo-controlled, parallel groups phase Ⅲ trail of Anyu Peibo Capsule in China, to aim whether the administration of Anyu Peibo Capsule compared to placebo improves clinical outcome in adults (18 years to 65 years) with MDD. The subjects will receive 8-week treatment with Anyu Peibo Capsule 1.6 g per day or placebo. The primary outcome will be the change of total score from baseline to the end of week 8 in Montgomery Asberg Depression Rating Scale.Discussion: The trial aims to provide pivotal evidence on the efficacy and safety of Anyu Peibo Capsule in patients with major depressive disorder. Trial registration: ClinicalTrials.gov, NCT04210973. Registered on December 26, 2019. https://www.clinicaltrials.gov/ct2/show/NCT04210973 Protocol version 1.2 from 29 August 2019.

Propofol Anaesthesia in Electroconvulsive Therapy

1994 ◽  
Vol 165 (4) ◽  
pp. 506-509 ◽  
Author(s):  
Christopher F. Fear ◽  
Carl S. Littlejohns ◽  
Eryl Rouse ◽  
Paul McQuail
Keyword(s):  
Major Depressive Disorder ◽  
Depressive Disorder ◽  
Electroconvulsive Therapy ◽  
Rating Scale ◽  
Induction Agent ◽  
Double Blind Study ◽  
Major Depressive ◽  
Seizure Duration ◽  
Double Blind ◽  
Induction Agents

BackgroundThe induction agent propofol is known to reduce electroconvulsive therapy (ECT) seizure duration. It is assumed that outcome from depression is adversely affected by this agent. This study compares propofol and methohexitone as induction agents for ECT.MethodIn a prospective, randomised, double-blind study 20 subjects with major depressive disorder (DSM-III-R criteria) received propofol or methohexitone anaesthesia. The Hamilton Depression Rating Scale and Beck Depression Inventory were used to assess depression before therapy, at every third treatment, and at the end of therapy. Seizure duration was measured using the cuff technique.ResultsMean seizure durations (P < 0.01) and mean total seizure duration (P < 0.01) were shorter in the propofol group. There was no difference in outcome.ConclusionsUse of propofol may not adversely affect outcome from depression and it is not necessarily contraindicated as an induction agent for ECT. Our results should be interpreted cautiously, and larger studies are needed.

EEG Synchronized TMS for Individualized Therapy in Major Depressive Disorder

2011 ◽  
Vol 26 (S2) ◽  
pp. 1144-1144
Author(s):  
Y. Jin ◽  
J. Phillips ◽  
Yueqin Huang ◽  
Steven Heurta
Keyword(s):  
Major Depressive Disorder ◽  
Side Effects ◽  
Depressive Disorder ◽  
Active Treatment ◽  
Rating Scale ◽  
Repetitive Transcranial Magnetic Stimulation ◽  
Stimulus Frequency ◽  
List Type ◽  
Major Depressive ◽  
Double Blind

IntroductionEfficacy of conventional repetitive transcranial magnetic stimulation (rTMS) in major depressive disorder (MDD) is limited. The authors report here on an alternative treatment using low energy synchronized TMS (sTMS) at the intrinsic frequency of subjects’ alpha electroencephalogram (EEG).ObjectivesEstablish efficacy and safety profile of sTMS in MDD.Aim(1)Examine the clinical effectiveness of sTMS.(2)Identify adverse effects associated with sTMS.MethodsFifty-two MDD subjects with 17-item Hamilton Depression Rating Scale (HAMD17) scores >17 were enrolled into a randomized, sham controlled, double-blind trial. Current medication remained unchanged during the trial. Depressive symptoms were evaluated by HAMD17 administered weekly.EEGs were recorded at baseline to determine the stimulus frequency and at week 4 to evaluate the physiological effect. sTMS was delivered through three 6000-G cylindrical neodymium magnets synchronously rotating at a rate equal to the subject's intrinsic alpha frequency.ResultsForty-five subjects completed at least 1 week of treatment and were evaluable. Those who received active treatment had superior clinical response to sham (t = 2.54, P = 0.01), where 55.2% in the active treatment group were clinical responders versus 12.5% in sham (X2 = 7.82, P = 0.005). No significant side effects were reported. The clinical improvement was correlated with the degree of EEG improvement (r = .46, P = 0.009).ConclusionsA therapeutic effect in MDD subjects can be achieved through administration of sTMS at the subject's alpha EEG frequency. Because of minimal side effects, this appears to be a safe and effective treatment option.

scholarly journals A Randomized, Double-Blind, Placebo-Controlled Trial of Escitalopram in Patients with Asthma and Major Depressive Disorder

2018 ◽  
Vol 6 (5) ◽  
pp. 1604-1612 ◽  
Author(s):  
E. Sherwood Brown ◽  
Nasreen Sayed ◽  
Erin Van Enkevort ◽  
Alexandra Kulikova ◽  
Alyson Nakamura ◽  
...  
Keyword(s):  
Major Depressive Disorder ◽  
Depressive Disorder ◽  
Controlled Trial ◽  
Major Depressive ◽  
Double Blind ◽  
Double Blind Placebo
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