NCT03868839

Telmisartan Pilot Study on Treatment Resistant Schizophrenia

Terminated Phase 2 Results posted Last updated 2 March 2022

What this trial tests

Phase 2 trial testing Telmisartan Pill in Schizophrenia in 6 participants. Terminated before completion.

Timeline

1 February 2019

Primary endpoint
7 October 2020

7 October 2020

Quick facts

Lead sponsor	Xiaoduo Fan
Phase	Phase 2
Status	Terminated
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	other
Enrollment	6
Start date	1 February 2019
Primary completion	7 October 2020
Estimated completion	7 October 2020
Sites	1 location across United States

Drugs / interventions tested

• Telmisartan Pill — full drug profile →

Conditions studied

• Schizophrenia — all drugs for Schizophrenia →
• Schizo Affective Disorder — all drugs for Schizo Affective Disorder →
• Treatment-resistant Schizophrenia — all drugs for Treatment-resistant Schizophrenia →

Sponsor

Xiaoduo Fan — full company profile →

Who can join

Adults 18 to 65, any sex, with Schizophrenia or Schizo Affective Disorder. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Changes in Blood Levels of Tumor Necrosis Factor Alpha Primary · Baseline (week 0) to 4 weeks after initial dose

Levels at week 4 minus levels at baseline

Group	Value	95% CI
Telmisartan Pill	1.10	± 0.2377

Changes in Blood Levels of Glutathione Primary · Baseline (week 0) to 4 weeks after initial dose

Levels at week 4 minus levels at baseline

Group	Value	95% CI
Telmisartan Pill	537.00	± 196.404

Changes in Blood Levels of Interleukin-6 Primary · Baseline (week 0) to 4 weeks after initial dose

Levels at week 4 minus levels at baseline

Group	Value	95% CI
Telmisartan Pill	4.61	± 3.4472

Changes in Blood Levels of High Sensitivity C-Reactive Protein Primary · Baseline (week 0) to 4 weeks after initial dose

Levels at week 4 minus levels at baseline

Group	Value	95% CI
Telmisartan Pill	2.34	± 1.9642

Adverse events — posted to ClinicalTrials.gov

Time frame: 4 weeks. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Telmisartan Pill

Serious: 0/6 (0%)

Deaths: 0/6

Other adverse events (1 terms — click to expand)

Reaction	System	Telmisartan Pill
Blurred vision	Eye disorders	—

Data from ClinicalTrials.gov NCT03868839 adverse events section.

Sponsor's own description

This study is a 4-week pilot study for subjects with Schizophrenia or Schizoaffective Disorder who have not experienced a significant relief of symptoms from current anti-psychotic medication. The Investigators hypothesize that 4 weeks of telmisartan at 80mg daily will alter blood biomarkers for inflammation and oxidative stress after 4 weeks treatment.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Treatment resistance in psychiatry: state of the art and new directions.
   Howes OD, Thase ME, Pillinger T. · · 2022 · cited 250× · PMID 34257409 · DOI 10.1038/s41380-021-01200-3
2. Is There a Glutathione Centered Redox Dysregulation Subtype of Schizophrenia?
   Palaniyappan L, Park MTM, Jeon P, Limongi R, et al · · 2021 · cited 18× · PMID 34829575 · DOI 10.3390/antiox10111703