Trial Outcomes & Findings for Telmisartan as an Adjunctive Treatment for Metabolic Problems in Patients With Schizophrenia (NCT NCT00981526)

Results Overview

Insulin resistance as estimated by homeostasis model of assessment of insulin resistance (HOMA-IR) at week 12 in both the experimental and placebo arm. Insulin resistance is a condition in which cells fail to respond to the normal action of the hormone in the body. The HOMA-IR is calculated using a subject's fasting plasma insulin and glucose levels. The higher the score, the higher the level of insulin resistance.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

66 participants

Primary outcome timeframe

12 weeks

Results posted on

2018-06-19

Participant Flow

A total of 66 subjects were screened, 4 of which were screen fails. 62 subjects were then enrolled. Prior to randomization, 8 subjects withdrew consent. 54 subjects were randomized.

Participant milestones

Participant milestones
Measure	A: Telmisartan Telmisartan 80mg/day	B: Placebo Placebo
Overall Study STARTED	26	28
Overall Study COMPLETED	22	22
Overall Study NOT COMPLETED	4	6

Reasons for withdrawal

Reasons for withdrawal
Measure	A: Telmisartan Telmisartan 80mg/day	B: Placebo Placebo
Overall Study Withdrawal by Subject	0	2
Overall Study Physician Decision	4	4

Baseline Characteristics

Telmisartan as an Adjunctive Treatment for Metabolic Problems in Patients With Schizophrenia

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	A: Telmisartan n=26 Participants Telmisartan 80mg/day	B: Placebo n=28 Participants Placebo Group	Total n=54 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Age, Categorical Between 18 and 65 years	26 Participants n=93 Participants	28 Participants n=4 Participants	54 Participants n=27 Participants
Age, Categorical >=65 years	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Age, Continuous	41.65 years STANDARD_DEVIATION 12.14 • n=93 Participants	44.68 years STANDARD_DEVIATION 11.02 • n=4 Participants	43.22 years STANDARD_DEVIATION 11.56 • n=27 Participants
Sex: Female, Male Female	4 Participants n=93 Participants	23 Participants n=4 Participants	27 Participants n=27 Participants
Sex: Female, Male Male	22 Participants n=93 Participants	5 Participants n=4 Participants	27 Participants n=27 Participants

PRIMARY outcome

Timeframe: 12 weeks

Insulin resistance as estimated by homeostasis model of assessment of insulin resistance (HOMA-IR) at week 12 in both the experimental and placebo arm. Insulin resistance is a condition in which cells fail to respond to the normal action of the hormone in the body. The HOMA-IR is calculated using a subject's fasting plasma insulin and glucose levels. The higher the score, the higher the level of insulin resistance.

Outcome measures

Outcome measures
Measure	A: Telmisartan n=22 Participants Telmisartan 80mg/day	B: Placebo n=22 Participants Placebo Group
Insulin Resistance	1.9997 HOMA-IR scores Standard Deviation 1.4262	2.5824 HOMA-IR scores Standard Deviation 2.469

PRIMARY outcome

Timeframe: 12 weeks

Fasting triglycerides assessed in both experimental and placebo arm at week 12.

Outcome measures

Outcome measures
Measure	A: Telmisartan n=22 Participants Telmisartan 80mg/day	B: Placebo n=22 Participants Placebo Group
Triglycerides	154.15 mg/dl Standard Deviation 156.02	176.72 mg/dl Standard Deviation 96.65

SECONDARY outcome

Timeframe: 12 weeks

Lipid metabolism - fasting low density lipoprotein (LDL) and high density lipoprotein (HDL) are estimated in both experimental and placebo arms at 12 weeks.

Outcome measures

Outcome measures
Measure	A: Telmisartan n=22 Participants Telmisartan 80mg/day	B: Placebo n=22 Participants Placebo Group
Lipid Metabolism - LDL-cholesterol and HDL-cholesterol LDL-cholesterol	107 mg/dl Standard Deviation 35.71	107.85 mg/dl Standard Deviation 31.57
Lipid Metabolism - LDL-cholesterol and HDL-cholesterol HDL-cholesterol	41.05 mg/dl Standard Deviation 9.59	43.18 mg/dl Standard Deviation 11.71

SECONDARY outcome

Timeframe: 12 weeks

The Positive and Negative Syndrome Scale (PANSS) and Scale for the Assessment of Negative Symptoms (SANS) were used to assess the positive and negative symptoms in experimental and placebo arms at 12 weeks. The PANSS total scale includes positive and negative subscales. For both subscales, the score ranges from 7-49 and total PANSS score ranges from 30-210. The total scale is a summation of all the subscales. The SANS score ranges from 0-100. For all scales, a greater score represents a worse outcome.

Outcome measures

Outcome measures
Measure	A: Telmisartan n=22 Participants Telmisartan 80mg/day	B: Placebo n=22 Participants Placebo Group
Psychopathology - PANSS Total, PANSS - Negative Score, PANNS - Positive Score and SANS - Total Scores. PANSS total score	67.41 units on a scale Standard Deviation 13.36	71.05 units on a scale Standard Deviation 20.32
Psychopathology - PANSS Total, PANSS - Negative Score, PANNS - Positive Score and SANS - Total Scores. PANSS negative score	19.55 units on a scale Standard Deviation 5.80	19.95 units on a scale Standard Deviation 5.09
Psychopathology - PANSS Total, PANSS - Negative Score, PANNS - Positive Score and SANS - Total Scores. PANSS positive score	15.50 units on a scale Standard Deviation 5.55	16.68 units on a scale Standard Deviation 7.64
Psychopathology - PANSS Total, PANSS - Negative Score, PANNS - Positive Score and SANS - Total Scores. SANS total score	27.82 units on a scale Standard Deviation 11.27	29.28 units on a scale Standard Deviation 10.96

SECONDARY outcome

Timeframe: 12 weeks

Body composition as estimated by waist to hip ratio in both experimental and placebo arms at 12 weeks.

Outcome measures

Outcome measures
Measure	A: Telmisartan n=22 Participants Telmisartan 80mg/day	B: Placebo n=22 Participants Placebo Group
Body Composition: Waist to Hip Ratio	0.99 Ratio Standard Deviation 0.08	0.95 Ratio Standard Deviation 0.23

SECONDARY outcome

Timeframe: 12 weeks

Body composition estimated by percent total body fat as measured by a dual energy absorptiometry (DXA) scan in both experimental and placebo arms at 12 weeks.

Outcome measures

Outcome measures
Measure	A: Telmisartan n=22 Participants Telmisartan 80mg/day	B: Placebo n=22 Participants Placebo Group
Body Composition: Percent Total Body Fat	31.9 percentage of body fat Standard Deviation 9.88	31.28 percentage of body fat Standard Deviation 9.02

Adverse Events

A: Experimental

Serious events: 0 serious events

Other events: 8 other events

Deaths: 0 deaths

B: Placebo

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	A: Experimental n=22 participants at risk Telmisartan 80mg/day	B: Placebo n=22 participants at risk Placebo Group
Gastrointestinal disorders Diarrhea	13.6% 3/22 • Number of events 3	4.5% 1/22 • Number of events 1
General disorders Dizziness	13.6% 3/22 • Number of events 3	4.5% 1/22 • Number of events 1
General disorders Chest pain	9.1% 2/22 • Number of events 2	0.00% 0/22

Additional Information

Dr. Xiaoduo Fan

UMass Medical School

Phone: 508-856-3881

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place