Evidence map›Paper›PMID 26143058›Full record

Trial reportQuality of life research : an international journal of quality of life aspects of treatment, care and rehabilitation2016

Health-related quality of life in patients with prominent negative symptoms: results from a multicenter randomized Phase II trial on bitopertin.

Diana Rofail, Antoine Regnault, Stéphanie le Scouiller, Carmen Galani Berardo, Daniel Umbricht, Ray Fitzpatrick

Registry-linked trialAbstract readClinical Trial, Phase IIMulticenter StudyRandomized Controlled Trial
PubMed Publisher
In one paragraph

Trial report in Quality of life research : an international journal of quality of life aspects of treatment, care and rehabilitation, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03667729 (The Effects of Progressive Muscle Relaxation Therapy in Patients With Schizophrenia), which is not on this map. Cited by 8 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
8citing papers in PubMed, 1 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.

NCT03667729 nacompletednot on this map

The Effects of Progressive Muscle Relaxation Therapy in Patients With Schizophrenia: Randomized Controlled Trials

TypeinterventionalSponsorTaipei Medical UniversityRan2014 to 2015Enrolled75ConditionsAffective Disorders, Psychotic DisorderArmsprogressive muscle relaxation
3 · Its place in the literature

Who cites it

8 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
  2. Article
  3. Review
  4. Pharmacokinetic profile of bitopertin, a selective GlyTNaunyn-Schmiedeberg's archives of pharmacology · 2023
    Article
  5. Article
  6. Review
  7. Article
  8. 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

6 authors.

Diana RofailRoche Products LTD, Shire Park, Welwyn Garden City, Hertfordshire, UK.
Antoine RegnaultMapi, HEOR & Strategic Market Access, 27, rue de la Villette, 69003, Lyon, France. aregnault@mapigroup.com.
Stéphanie le ScouillerRoche Products LTD, Shire Park, Welwyn Garden City, Hertfordshire, UK.
Carmen Galani BerardoF Hoffmann - La Roche, Grenzacherstrasse 124, Basel, Switzerland.
Daniel UmbrichtF Hoffmann - La Roche, Grenzacherstrasse 124, Basel, Switzerland.
Ray FitzpatrickUniversity of Oxford, Wellington Square, Oxford, UK.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purposeSymptoms of schizophrenia fall into three categories (positive, negative and cognitive symptoms), which probably impact differently on patient's health-related quality of life (HRQoL). The present study aimed to explore HRQoL in patients with prominent negative symptoms.

methodsIn the 323 patients with prominent negative symptoms included in a multicenter Phase II trial investigating the safety and efficacy of bitopertin, HRQoL was assessed using the Schizophrenia Quality of Life Scale (SQLS), symptoms severity using the Positive and Negative Syndrome Scale and functioning using the Personal and Social Performance Scale. SQLS measurement properties were assessed; HRQoL was compared between treatment arms, and relationships between HRQoL, symptoms and functioning at baseline were explored.

resultsBoth SQLS scores (Vitality/Cognition and Psychosocial Feelings) demonstrated good test-retest (ICC = 0.77 and 0.74) and internal consistency reliability (Cronbach's α = 0.86 and 0.93). Clinical validity with regard to schizophrenia severity and ability to detect change in severity of symptoms of schizophrenia were satisfactory. The SQLS structure was not formally disconfirmed. No statistically significant difference was observed between treatment arms. Negative symptoms were more strongly associated with functioning than positive symptoms. Functioning and Anxiety/Depression were strongly related to both SQLS domains.

conclusionOverall, SQLS measurement properties were supported in these patients with prominent negative symptoms of schizophrenia. The impact of negative symptoms on functioning and HRQoL suggests that improving these symptoms will be a meaningful benefit in this population of patients.

Indexed as

Health StatusAdultFemaleHumansMaleMiddle AgedPiperazinesQuality of LifeReproducibility of ResultsSchizophreniaSulfonesSurveys and Questionnaires(4-(3-fluoro-5-trifluoromethylpyridin-2-yl)piperazin-1-yl)(5-methanesulfonyl-2-(2,2,2-trifluoro-1-methylethoxy)phenyl)methanonePiperazinesSulfonesBitopertinNegative symptomsQuality of lifeSchizophrenia

Identifiers

PMID26143058

What OpenQuestion holds

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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.