Evidence map›Paper›PMID 30045066›Full record

Trial reportInternational clinical psychopharmacology2018

Efficacy of adjunctive low-dose cariprazine in major depressive disorder: a randomized, double-blind, placebo-controlled trial.

Maurizio Fava, Suresh Durgam, Willie Earley, Kaifeng Lu, Robert Hayes, István Laszlovszky, György Németh

Registry-linked trialAbstract readClinical Trial, Phase IIRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in International clinical psychopharmacology, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00854100 (A Double-Blind, Placebo-Controlled Study of Cariprazine), which is not on this map. Cited by 29 papers, 7 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
29citing papers in PubMed, 7 pooled it
–field-weighted citation impact
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.

NCT00854100 phase2completednot on this map

A Double-Blind, Placebo-Controlled Study of Cariprazine (RGH-188) As Adjunctive Therapy In Major Depressive Disorder

TypeinterventionalSponsorForest LaboratoriesRan2009 to 2010Enrolled231ConditionsMajor Depressive DisorderArmsAntidepressant + placebo, Antidepressant + cariprazine (0.1-0.3 mg/day), Antidepressant + cariprazine (1-2 mg/d)
3 · Its place in the literature

Who cites it

29 citing papers in PubMed, 7 syntheses or guidelines pooled it.

  1. Pooled it
  2. Pooled it
  3. Pooled it
  4. Pooled it
  5. Pooled it
  6. Pooled it
  7. Pharmacological interventions for treatment-resistant depression in adults.The Cochrane database of systematic reviews · 2019
    Pooled it
  8. Trial
  9. Article
  10. Review
  11. Review
  12. Article
  13. Review
  14. Review
  15. Treatment-resistant depression: definition, prevalence, detection, management, and investigational interventions.World psychiatry : official journal of the World Psychiatric Association (WPA) · 2023
    Article
  16. Article
  17. Review
  18. Article
  19. Article
  20. Case Report: Long-Acting Oral Cariprazine.Frontiers in psychiatry · 2022
    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

7 authors.

Maurizio FavaDepartment of Psychiatry, Massachusetts General Hospital, Boston, Massachusetts.
Suresh DurgamDepartments of Clinical Development.
Willie EarleyDepartments of Clinical Development.
Kaifeng LuBiostatistics, Allergan Plc, Giralda Farms, Madison, New Jersey, USA.
Robert HayesDepartments of Clinical Development.
István LaszlovszkyMedical Division, Gedeon Richter Plc, Budapest, Hungary.
György NémethMedical Division, Gedeon Richter Plc, Budapest, Hungary.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

This 19-week, double-blind, placebo-controlled, randomized phase 2 study evaluated the efficacy, safety, and tolerability of adjunctive cariprazine (0.1-0.3 and 1.0-2.0 mg/day) as an antidepressant treatment for adults with treatment-resistant major depressive disorder (MDD) (NCT00854100). The primary endpoint was change in the Montgomery-Åsberg Depression Rating Scale (MADRS) total score and the secondary was change in the Clinical Global Impression-Intensity score. Additional efficacy parameters were also assessed. A total of 231 patients were randomized. None of the predefined parameters reached significance for either cariprazine doses, but higher doses yielded numerically greater mean changes in MADRS and Clinical Global Impression-Intensity scores, and MADRS response and remission rates, compared with placebo. No differences were seen on any measures between cariprazine 0.1-0.3 mg/day and placebo. Cariprazine was relatively well tolerated, and common treatment-emergent adverse events (incidence ≥5% and twice the placebo group rate) in both dosage groups included headache, arthralgia, restlessness, fatigue, increased appetite, insomnia, dry mouth, and constipation. In conclusion, both cariprazine doses were relatively well tolerated; although differences were not statistically significant, patients treated with cariprazine 1.0-2.0 mg/day had greater mean decreases in measures of depression symptoms compared with placebo, which is consistent with another adjunctive cariprazine MDD study, and thus warrants further investigation.

Indexed as

AdolescentAdultAgedAntidepressive AgentsAntipsychotic AgentsDepressive Disorder, Treatment-ResistantDose-Response Relationship, DrugDouble-Blind MethodDrug Therapy, CombinationFemaleHumansMajor Depressive DisorderMaleMiddle AgedPiperazinesPsychiatric Status Rating ScalesAntidepressive AgentsAntipsychotic AgentscariprazinePiperazines

Identifiers

PMID30045066
PMCPMC6166709

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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.