Evidence map›Paper›PMID 24801768›Full record

Trial reportNeuropsychopharmacology : official publication of the American College of Neuropsychopharmacology2014

Efficacy and safety of olanzapine/fluoxetine combination vs fluoxetine monotherapy following successful combination therapy of treatment-resistant major depressive disorder.

Elizabeth Brunner, Mauricio Tohen, Olawale Osuntokun, John Landry, Michael E Thase

Open access · hybridAbstract readClinical Trial, Phase IIIMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Neuropsychopharmacology : official publication of the American College of Neuropsychopharmacology, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 22 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
22citing papers in PubMed, 1 pooled it
6.6field-weighted citation impact, top 3% 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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

22 citing papers in PubMed, 1 synthesis or guideline pooled it, 52 citations in OpenAlex.

  1. Pooled it
  2. Trial
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  4. Trial
  5. Review
  6. Article
  7. Article
  8. Article
  9. Article
  10. The Combination ofFrontiers in pharmacology · 2020
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  11. Article
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  13. Review
  14. Article
  15. Article
  16. Article
  17. Review
  18. Article
  19. Bibliography: Depression: Challenges and Treatments.Focus (American Psychiatric Publishing) · 2016
    Article
  20. Efficacy of olanzapine in symptom relief and quality of life in gastric cancer patients receiving chemotherapy.Journal of research in medical sciences : the official journal of Isfahan University of Medical Sciences · 2016
    Article
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

5 authors at 4 institutions in 2 countries.

Elizabeth BrunnerEli Lilly and Company, Indianapolis, IN, USA.
Mauricio TohenDepartment of Psychiatry, Health Sciences Center, University of New Mexico, Albuquerque, NM, USA.
Olawale OsuntokunEli Lilly and Company, Indianapolis, IN, USA.
John LandryEli Lilly Canada, Toronto, ON, USA.
Michael E ThasePerelman School of Medicine of the University of Pennsylvania, Philadelphia Veterans Affairs Medical Center and the University of Pittsburgh Medical Center, Pittsburgh, PA, USA.
Eli Lilly (United States) · USEli Lilly (Canada) · CAUniversity of New Mexico · USUniversity of Pittsburgh Medical Center · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

This study assessed prevention of relapse in patients with treatment-resistant depression (TRD) taking olanzapine/fluoxetine combination (OFC). Patients with major depressive disorder (MDD) who failed to satisfactorily respond to ≥ 2 different antidepressants for ≥ 6 weeks within the current MDD episode were acutely treated for 6-8 weeks, followed by stabilization (12 weeks) on OFC. Those who remained stable were randomized to OFC or fluoxetine for up to 27 weeks. Time-to-relapse was the primary efficacy outcome defined as 50% increase in Montgomery-Åsberg Depression Rating Scale score with Clinical Global Impressions-Severity of Depression score of ≥ 4; hospitalization for depression or suicidality; or discontinuation for lack of efficacy or worsening of depression or suicidality. A total of 444 patients were randomized 1:1 to OFC (N=221) or fluoxetine (N=223). Time-to-relapse was significantly longer in OFC-treated patients compared with fluoxetine-treated patients (p<0.001). Treatment-emergent weight gain and some mean and categorical fasting metabolic changes were significantly greater in OFC-treated patients. Clinically significant weight gain (≥ 7%) was observed in 55.7% of patients who remained on OFC throughout the study, including the relapse-prevention phase (up to 47 weeks). There were no significant differences between patients treated with OFC and fluoxetine in extrapyramidal symptoms or serious adverse events. We believe this is the first controlled relapse-prevention study in subjects with TRD that supports continued use of a second-generation antipsychotic beyond stabilization. A thorough assessment of benefits and risks (in particular metabolic changes) associated with continuing treatment with OFC or fluoxetine must be done based on individual patient needs.

Indexed as

AdultAntidepressive AgentsBenzodiazepinesDepressive Disorder, Treatment-ResistantDouble-Blind MethodDrug CombinationsFemaleFluoxetineHospitalizationHumansKaplan-Meier EstimateMajor Depressive DisorderMaleMiddle AgedPsychiatric Status Rating ScalesSecondary PreventionAntidepressive AgentsBenzodiazepinesDrug CombinationsFluoxetineolanzapine-fluoxetine combination

Identifiers

PMID24801768
PMCPMC4207330
OpenAlexW1973061797

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
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Registered trials

None linked

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.