Trial · NCT00981526
Telmisartan as an Adjunctive Treatment for Metabolic Problems in Patients With Schizophrenia
NCT00981526, Phase 4, Completed, University of Massachusetts, Worcester; results first posted 2018-06-19
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Telmisartan as an Adjunctive Treatment for Metabolic Problems in Patients With Schizophrenia. Trials, record NCT00981526. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00981526
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Telmisartan as an Adjunctive Treatment for Metabolic Problems in Patients With Schizophrenia
- NCT number
- NCT00981526
- Status
- Completed
- Phases
- Phase 4
- Enrollment
- 66 participants, actual
- Lead sponsor
- University of Massachusetts, Worcester
- Conditions
- Schizophrenia, Schizoaffective Disorder
- Interventions
- Telmisartan, Placebo, Clozapine, Olanzapine
- First posted
- 2009-09-22
- Last updated
- 2018-06-19
- Results first posted
- 2018-06-19
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Insulin Resistance | 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. |
| Primary | Triglycerides | 12 weeks | Fasting triglycerides assessed in both experimental and placebo arm at week 12. |
| Secondary | Lipid Metabolism - LDL-cholesterol and HDL-cholesterol | 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. |
| Secondary | Psychopathology - PANSS Total, PANSS - Negative Score, PANNS - Positive Score and SANS - Total Scores. | 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. |
| Secondary | Body Composition: Waist to Hip Ratio | 12 weeks | Body composition as estimated by waist to hip ratio in both experimental and placebo arms at 12 weeks. |
| Secondary | Body Composition: Percent Total Body Fat | 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. |
Source ClinicalTrials.gov
Outcomes6
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Insulin Resistance | 12 weeks | HOMA-IR scores | MEAN | |
| PRIMARY | Triglycerides | 12 weeks | mg/dl | MEAN | |
| SECONDARY | Lipid Metabolism - LDL-cholesterol and HDL-cholesterol | 12 weeks | mg/dl | MEAN | |
| SECONDARY | Psychopathology - PANSS Total, PANSS - Negative Score, PANNS - Positive Score and SANS - Total Scores. | 12 weeks | units on a scale | MEAN | |
| SECONDARY | Body Composition: Waist to Hip Ratio | 12 weeks | Ratio | MEAN | |
| SECONDARY | Body Composition: Percent Total Body Fat | 12 weeks | percentage of body fat | MEAN |
Source ClinicalTrials.gov
Results by group20
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Insulin Resistance | A: Telmisartan | 1.9997 | Standard Deviation 1.4262 | HOMA-IR scores | |
| Insulin Resistance | B: Placebo | 2.5824 | Standard Deviation 2.469 | HOMA-IR scores | |
| Triglycerides | A: Telmisartan | 154.15 | Standard Deviation 156.02 | mg/dl | |
| Triglycerides | B: Placebo | 176.72 | Standard Deviation 96.65 | mg/dl | |
| Lipid Metabolism - LDL-cholesterol and HDL-cholesterol | A: Experimental | LDL-cholesterol | 107 | Standard Deviation 35.71 | mg/dl |
| Lipid Metabolism - LDL-cholesterol and HDL-cholesterol | B: Placebo | LDL-cholesterol | 107.85 | Standard Deviation 31.57 | mg/dl |
| Lipid Metabolism - LDL-cholesterol and HDL-cholesterol | A: Experimental | HDL-cholesterol | 41.05 | Standard Deviation 9.59 | mg/dl |
| Lipid Metabolism - LDL-cholesterol and HDL-cholesterol | B: Placebo | HDL-cholesterol | 43.18 | Standard Deviation 11.71 | mg/dl |
| Psychopathology - PANSS Total, PANSS - Negative Score, PANNS - Positive Score and SANS - Total Scores. | A: Experimental | PANSS total score | 67.41 | Standard Deviation 13.36 | units on a scale |
| Psychopathology - PANSS Total, PANSS - Negative Score, PANNS - Positive Score and SANS - Total Scores. | B: Placebo | PANSS total score | 71.05 | Standard Deviation 20.32 | units on a scale |
1 to 10 of 20Source ClinicalTrials.gov
See all 20 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | A: Telmisartan | 26 | |
| Overall Study | STARTED | B: Placebo | 28 | |
| Overall Study | COMPLETED | A: Telmisartan | 22 | |
| Overall Study | COMPLETED | B: Placebo | 22 | |
| Overall Study | NOT COMPLETED | A: Telmisartan | 4 | |
| Overall Study | NOT COMPLETED | B: Placebo | 6 |
Source ClinicalTrials.gov
Adverse events6
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Diarrhea | Gastrointestinal disorders | A: Experimental | 3 | 22 | 3 |
| other | Diarrhea | Gastrointestinal disorders | B: Placebo | 1 | 22 | 1 |
| other | Dizziness | General disorders | A: Experimental | 3 | 22 | 3 |
| other | Dizziness | General disorders | B: Placebo | 1 | 22 | 1 |
| other | Chest pain | General disorders | A: Experimental | 2 | 22 | 2 |
| other | Chest pain | General disorders | B: Placebo | 0 | 22 | 0 |
Source ClinicalTrials.gov
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | A: Experimental | ||
| Total, all-cause mortality | B: Placebo | ||
| Total, other adverse events | A: Experimental | 8 | 22 |
| Total, other adverse events | B: Placebo | 2 | 22 |
| Total, serious adverse events | A: Experimental | 0 | 22 |
| Total, serious adverse events | B: Placebo | 0 | 22 |
Source ClinicalTrials.gov
Papers2
The papers the trial lists on ClinicalTrials.gov.
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 comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| A: Experimental vs B: Placebo: serious adverse events |
Source Trial comparisons
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.
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/NCT00981526
GET https://conductscience.org/api/trials/v1/NCT00981526/registered