Evidence map›Paper›PMID 25980552›Full record

Trial reportInternational journal of clinical practice2015

Changes in energy during treatment of depression: an analysis of duloxetine in double-blind placebo-controlled trials.

E Harada, M Kato, S Fujikoshi, M M Wohlreich, L Berggren, H Tokuoka

4 registry-linked trialsOpen access · hybridAbstract readMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in International journal of clinical practice, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 4 registered trials, which are not on this map. Cited by 5 papers.

0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed
0.6field-weighted citation impact, top 28% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT00036335 phase3completednot on this map

Duloxetine Hydrochloride (LY248686) Protocol F1J-US-HMCB Duloxetine Once-Daily Dosing Versus Placebo in Patients With Major Depression and Pain

TypeinterventionalSponsorEli Lilly and CompanyRan2002 to 2003Enrolled286ConditionsDepression, PainArmsDuloxetine Hydrochloride
NCT00073411 phase3completednot on this map

Duloxetine Versus Escitalopram and Placebo in the Treatment of Patients With Major Depression

TypeinterventionalSponsorEli Lilly and CompanyRan2003 to 2005Enrolled675ConditionsDepressionArmsduloxetine, escitalopram, placebo
NCT00406848 phase4completednot on this map

Duloxetine Versus Placebo in the Long-Term Treatment of Patients With Late-Life Major Depression

TypeinterventionalSponsorEli Lilly and CompanyRan2006 to 2009Enrolled370ConditionsMajor Depressive DisorderArmsduloxetine hydrochloride, placebo
NCT00536471 phase4completednot on this map

Duloxetine Versus Placebo in Patients With Major Depressive Disorder (MDD): Assessment of Energy and Vitality in MDD

TypeinterventionalSponsorEli Lilly and CompanyRan2007 to 2008Enrolled776ConditionsMajor Depressive DisorderArmsDuloxetine hydrochloride, Placebo
3 · Its place in the literature

Who cites it

5 citing papers in PubMed, 7 citations in OpenAlex.

  1. Adjunctive Bright Light Therapy for Non-Seasonal Major Depressive Disorder: A Randomized Controlled Trial.International journal of environmental research and public health · 2022
    Trial
  2. Article
  3. Article
  4. Article
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

6 authors at 4 institutions in 3 countries.

E HaradaMedical Science, Eli Lilly Japan K.K., Hyogo, Japan.
M KatoDepartment of Neuropsychiatry, Kansai Medical University, Osaka, Japan.
S FujikoshiStatistical Science, Eli Lilly Japan K.K., Hyogo, Japan.
M M WohlreichNeuroscience, Eli Lilly and Company, Indianapolis, IN, USA.
L BerggrenGlobal Statistical Sciences, Eli Lilly and Company, Bad Homburg, Germany.
H TokuokaMedical Science, Eli Lilly Japan K.K., Hyogo, Japan.
Eli Lilly (United States) · USEli Lilly (Germany) · DEEli Lilly (Japan) · JPKansai Medical University · JP

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

aimsThe aim of this study was to assess how quickly and effectively duloxetine improves energy compared with placebo in patients with major depressive disorder (MDD).

methodsData from 10 randomised, double-blind, placebo-controlled clinical trials examining duloxetine (40-60 mg/day) vs. placebo in patients diagnosed with MDD were analysed. Change from baseline at Week 1 through Week 8 in Hamilton Depression Rating Scale (HAM-D) retardation subscale score (Item 1 - depressed mood, Item 7 - work and activities, Item 8 - retardation and Item 14 - genital symptoms) was assessed with mixed model repeated measures analysis. Positive predictive values and negative predictive values were calculated for predictor analysis.

resultsPatients treated with duloxetine (N = 1522) experienced statistically significantly (p ≤ 0.05) greater reductions in HAM-D retardation subscale scores vs. placebo (N = 1180) starting at Week 1 throughout Week 8 of treatment. Of the patients with early energy improvement (≥ 20% reduction in HAM-D retardation subscale scores) at Week 1, 48% achieved remission (HAM-D total score ≤ 7) at Week 8; 48% and 46% of patients who experienced early energy improvement at Weeks 2 and 4, respectively, achieved remission at Week 8. DISCUSSION: We demonstrated that treatment with duloxetine, quickly and with increasing magnitude over treatment time, improves low energy symptoms. As early as 1 week after starting treatment with duloxetine, improvement of low energy may serve as a predictor of remission at end-point.

conclusionsTreatment with duloxetine improves energy in patients with MDD and early response in retardation may serve as a modest predictor of remission at end-point. CLINICAL TRIALS REGISTRATION: ClinicalTrials.gov. Study Identifiers: NCT00036335; NCT00073411; NCT00406848 and NCT00536471. Studies HMAQa, HMAQb, HMATa, HMATb, HMBHa and HMBHb predate the registration requirement. DATA POSTING: ClinicalTrials.gov. Study Identifiers: NCT00406848; NCT00536471.

Indexed as

Antidepressive AgentsDepressionDose-Response Relationship, DrugDouble-Blind MethodDuloxetine HydrochlorideEnergy MetabolismFemaleFollow-Up StudiesHumansMaleMiddle AgedPsychiatric Status Rating ScalesSeverity of Illness IndexTreatment OutcomeAntidepressive AgentsDuloxetine Hydrochloride

Identifiers

PMID25980552
PMCPMC4682452
OpenAlexW1716068194

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.