Trial Outcomes & Findings for Telmisartan Pilot Study on Treatment Resistant Schizophrenia (NCT NCT03868839)

Results Overview

Levels at week 4 minus levels at baseline

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

6 participants

Primary outcome timeframe

Baseline (week 0) to 4 weeks after initial dose

Results posted on

2022-03-02

Participant Flow

Participant milestones

Participant milestones
Measure	Telmisartan Pill Subjects will start telmisartan 40mg once a day during week 1; the dose will be increased to 80mg (target dose) or as tolerated during the remaining three weeks. Telmisartan Pill: telmisartan 40mg once a day during week 1; the dose will be increased to 80mg (target dose) or as tolerated during the remaining three weeks.
Overall Study STARTED	6
Overall Study COMPLETED	5
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Telmisartan Pilot Study on Treatment Resistant Schizophrenia

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Telmisartan Pill n=6 Participants Subjects will start telmisartan 40mg once a day during week 1; the dose will be increased to 80mg (target dose) or as tolerated during the remaining three weeks. Telmisartan Pill: telmisartan 40mg once a day during week 1; the dose will be increased to 80mg (target dose) or as tolerated during the remaining three weeks.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	6 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age, Continuous	33.67 years STANDARD_DEVIATION 11.27 • n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants
Sex: Female, Male Male	6 Participants n=5 Participants
Race/Ethnicity, Customized White	4 Participants n=5 Participants
Race/Ethnicity, Customized Black	1 Participants n=5 Participants
Race/Ethnicity, Customized Two or more races	1 Participants n=5 Participants
Region of Enrollment United States	6 participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline (week 0) to 4 weeks after initial dose

Levels at week 4 minus levels at baseline

Outcome measures

Outcome measures
Measure	Telmisartan Pill n=5 Participants Subjects will start telmisartan 40mg once a day during week 1; the dose will be increased to 80mg (target dose) or as tolerated during the remaining three weeks. Telmisartan Pill: telmisartan 40mg once a day during week 1; the dose will be increased to 80mg (target dose) or as tolerated during the remaining three weeks.
Changes in Blood Levels of Tumor Necrosis Factor Alpha	1.10 pg/mL Standard Deviation 0.2377

PRIMARY outcome

Timeframe: Baseline (week 0) to 4 weeks after initial dose

Levels at week 4 minus levels at baseline

Outcome measures

Outcome measures
Measure	Telmisartan Pill n=5 Participants Subjects will start telmisartan 40mg once a day during week 1; the dose will be increased to 80mg (target dose) or as tolerated during the remaining three weeks. Telmisartan Pill: telmisartan 40mg once a day during week 1; the dose will be increased to 80mg (target dose) or as tolerated during the remaining three weeks.
Changes in Blood Levels of Glutathione	537.00 uM Standard Deviation 196.404

PRIMARY outcome

Timeframe: Baseline (week 0) to 4 weeks after initial dose

Levels at week 4 minus levels at baseline

Outcome measures

Outcome measures
Measure	Telmisartan Pill n=5 Participants Subjects will start telmisartan 40mg once a day during week 1; the dose will be increased to 80mg (target dose) or as tolerated during the remaining three weeks. Telmisartan Pill: telmisartan 40mg once a day during week 1; the dose will be increased to 80mg (target dose) or as tolerated during the remaining three weeks.
Changes in Blood Levels of Interleukin-6	4.61 pg/mL Standard Deviation 3.4472

PRIMARY outcome

Timeframe: Baseline (week 0) to 4 weeks after initial dose

Levels at week 4 minus levels at baseline

Outcome measures

Outcome measures
Measure	Telmisartan Pill n=5 Participants Subjects will start telmisartan 40mg once a day during week 1; the dose will be increased to 80mg (target dose) or as tolerated during the remaining three weeks. Telmisartan Pill: telmisartan 40mg once a day during week 1; the dose will be increased to 80mg (target dose) or as tolerated during the remaining three weeks.
Changes in Blood Levels of High Sensitivity C-Reactive Protein	2.34 mg/L Standard Deviation 1.9642

Adverse Events

Telmisartan Pill

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Telmisartan Pill n=6 participants at risk Subjects will start telmisartan 40mg once a day during week 1; the dose will be increased to 80mg (target dose) or as tolerated during the remaining three weeks. Telmisartan Pill: telmisartan 40mg once a day during week 1; the dose will be increased to 80mg (target dose) or as tolerated during the remaining three weeks.
Eye disorders Blurred vision	16.7% 1/6 • Number of events 1 • 4 weeks

Additional Information

Xiaoduo Fan

University of Massachusetts Medical School

Phone: 5088563881

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place