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Trial · NCT03043820

Raloxifene Augmentation in Patients With a Schizophrenia Spectrum Disorder

NCT03043820, Phase 3, Completed, Iris Sommer

3 sourcestrials-2026-11-12-0.5.0

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ConductScience Library. Raloxifene Augmentation in Patients With a Schizophrenia Spectrum Disorder. Trials, record NCT03043820. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03043820

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title
Raloxifene Augmentation in Patients With a Schizophrenia Spectrum Disorder
NCT number
NCT03043820
Status
Completed
Phases
Phase 3
Enrollment
110 participants, actual
Lead sponsor
Iris Sommer
Conditions
Schizophrenia, Schizoaffective Disorder, Schizophreniform Disorder, Psychosis NOS
Interventions
Raloxifene, Placebo
First posted
2017-02-06
Last updated
2021-10-08
Other registries' IDs
eudract:2015-004483-11

Source ClinicalTrials.gov

Registered outcomes12

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

ListOutcomeTime frameDescription
PrimaryChange in symptom severity as measured with the Positive and Negative Symptom Scale (PANSS)Baseline, at 6 weeks of treatment, at 12 weeks of treatment (end of treatment) and 6 months after end of treatment (follow-up)Effect of the study therapies on symptom severity.
PrimaryChange in cognitive functioning as measured with the Brief Assessment of Cognition in SchizophreniaBaseline, at 12 weeks (end of treatment) and 6 months after end of treatment (follow-up)Effect of the study therapies on cognitive functioning
SecondaryPersonal and social performance measured with the Personal and Social Performance scale (PSP)Baseline, at 6 weeks, at 12 weeks (end of treatment) and 6 months after end of treatment (follow-up)Effect of the study therapy on personal and social performance.
SecondaryThought disorder severity as measured with the Thought And Language Disorder scale (TALD)Baseline, at 6 weeks, at 12 weeks (end of treatment) and 6 months after end of treatment (follow-up)Effect of the study therapy on severity of thought disorder.
SecondaryParticipant's Quality of Life as measured with the EQ-5D-5LBaseline, at 12 weeks (end of treatment) and 6 months after end of treatment (follow-up)Effect of the study therapy on quality of life.
SecondaryComorbid depression as measured with Beck's Depression Inventory (BDI).Baseline, at 6 weeks, at 12 weeks (end of treatment) and 6 months after end of treatment (follow-up)Effect of the study therapy on comorbid depression
SecondaryUse of health-recourses as measured with the iMTA-MCQBaseline, at 12 weeks (end of treatment) and 6 months follow-upEffect of the study therapy on use of recourses.
SecondaryUse of non-health recourses as measured with the iMTA-PCQBaseline, at 12 weeks (end of treatment) and 6 months after end of treatment (follow-up)Effect of the study therapy on use of recourses.
SecondaryLanguage production assessment by analyzing speech samplesBaseline and at 12 weeks of treatment (end of treatment)Effect of the study therapy on free speech.
SecondarySymptom severity as measured with the Brief Negative Symptom Scale (BNSS)Baseline, at 6 weeks, at 12 weeks (end of treatment) and 6 months after end of treatment (follow-up)Effect of the study therapies on symptom severity.

Outcomes0

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

None in this release.

Results by group0

Each measurement the trial posted, group by group, in the words and numbers it posted.

None in this release.

Participant flow0

How many started, completed or left each group, period by period.

None in this release.

Adverse events0

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

None in this release.

Adverse event totals0

The totals the trial posted for each group.

None in this release.

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMIDListed as
25914107BACKGROUND

Source PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov
2026-11-12
ClinicalTrials.gov
Results, from AACT
2026-03-23
AACT
NIH grant links
2026-11-13
NIH RePORTER

Sources 3

  • ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
  • ClinicalTrials.govNo license stated
  • NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
  • ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
  • ClinicalTrials.govnone stated
  • NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT03043820

GET https://conductscience.org/api/trials/v1/NCT03043820/registered