Advertisement

Topics

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

2014-08-27 03:19:11 | BioPortfolio

Summary

This is a 12-week, randomized, double-blinded, placebo-controlled trial of telmisartan 80 mg/day as an adjunctive to clozapine or olanzapine therapy, in 70 schizophrenia subjects to examine telmisartan's effect on glucose metabolism, weight, food intake, resting energy expenditure, and body composition. In addition, the study will examine insulin's effects on psychopathology and cognition.

Potential subjects will be identified by their clinicians at the Freedom Trail Clinic, or Massachusetts General Hospital. A total of 70 subjects will be enrolled.

Description

The specific aims include:

Primary Aims:

1. Examine the efficacy of telmisartan added to regular doses of clozapine or olanzapine in improving insulin resistance.

2. Examine the efficacy of telmisartan in reducing fasting triglycerides.

Secondary Aims:

1. Examine the effects of telmisartan on negative symptoms, positive symptoms, and cognitive function.

2. Examine the efficacy of telmisartan in improving glucose metabolism as measured by glucose effectiveness (SG) and the acute insulin response to glucose (AIRG).

3. Examine telmisartan's effects on lipids, body composition, waist circumference, and waist/hip ratio.

4. Examine telmisartan's effects on weight, food intake and resting energy expenditure.

5. Characterize the relationships between changes in CRP, IL-6, and changes in fasting insulin and glucose, SI, SG, and AIRG from FSIVGTT.

6. Characterize the relationships between changes in fasting insulin and glucose, SI, SG, and AIRG from FSIVGTT, CRP, IL-6, and changes in negative symptoms, positive symptoms and cognitive function.

7. Examine telmisartan's effects on inflammatory biomarkers including C-reactive protein (CRP) and interleukin 6 (IL-6).

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Conditions

Schizophrenia

Intervention

Telmisartan, Placebo

Location

Massachusetts General Hospital
Boston
Massachusetts
United States
02116

Status

Recruiting

Source

Massachusetts General Hospital

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:19:11-0400

Clinical Trials [1134 Associated Clinical Trials listed on BioPortfolio]

Combination of Telmisartan 80 mg Plus Hydrochlorothiazide 12.5 mg to Telmisartan 80 mg in Patients Failed in Telmisartan 80 mg

To demonstrate that a fixed dose combination of telmisartan 80 mg plus HCTZ 12.5 mg is superior to telmisartan 80 mg alone in patients, who fail to respond adequately to telmisartan 80 mg ...

Telmisartan Plus Hydrochlorothiazide in Subjects With Mild-to-moderate Hypertension Who Failed to Respond to Telmisartan Monotherapy

An eight week study to compare the effect of a fixed dose combination of Telmisartan 40 mg plus hydrochlorothiazide (HCTZ) 12.5 mg to Telmisartan 40 mg alone on diastolic and systolic bloo...

Non-responder Study to Telmisartan 40 mg

The objective of this trial is to demonstrate that the fixed dose combination of telmisartan 40 mg and HCTZ 12.5 mg is superior to the monocomponent of telmisartan (Micardis, Gliosartan, K...

Filtered Trial for Telmisartan 40mg Non-responder

The primary purpose of this study is to: Demonstrate that a fixed-dose combination of telmisartan 40 mg plus amlodipine 5 mg is superior to telmisartan 40 mg alone in patients with essent...

Trial of Telmisartan 80 mg/HCTZ 12.5 mg and Telmisartan 40 mg/HCTZ 12.5 mg in Patients With Hypertension

The objective of this trial is to assess the safety and efficacy of 52 weeks of open-label treatment with the fixed dose combination of telmisartan 80 mg plus HCTZ 12.5 mg and telmisartan ...

PubMed Articles [1753 Associated PubMed Articles listed on BioPortfolio]

Acute toxic effects of telmisartan in spontaneously hypertensive rats fed a high fructose diet.

Telmisartan is an angiotensin receptor blocker (ARB) and a selective peroxisome proliferator activated receptor gamma (PPARG) modulator. Recently, we tested metabolic effects of telmisartan (5 mg/kg b...

Physiologically-based pharmacokinetic predictions of intestinal BCRP-mediated drug interactions of rosuvastatin in Koreans.

It was recently reported that the C and AUC of rosuvastatin increases when it is coadministered with telmisartan and cyclosporine. Rosuvastatin is known to be a substrate of OATP1B1, OATP1B3, NTCP, an...

Sodium nitroprusside treatment for psychotic symptoms and cognitive deficits of schizophrenia: A randomized, double-blind, placebo-controlled trial.

Schizophrenia presents with a broad range of negative, positive, and cognitive symptoms, and comprehensive treatment is still a challenge. Sodium nitroprusside (SNP) has been reported to rapidly reduc...

Efficacy of cariprazine on negative symptoms in patients with acute schizophrenia: A post hoc analysis of pooled data.

Although currently approved antipsychotics exert efficacy on positive symptoms of schizophrenia, treatments for negative symptoms remain a major unmet need. Post hoc analyses were used to investigate ...

Telmisartan Improves Insulin Resistance: A Meta-Analysis.

Diabetes mellitus, metabolic syndrome, and other obesity-related diseases are characterized by insulin resistance (IR) as a common pathophysiological change and are closely related to cardiovascular d...

Medical and Biotech [MESH] Definitions

A chronic form of schizophrenia characterized primarily by the presence of persecutory or grandiose delusions, often associated with hallucination.

A type of schizophrenia characterized by abnormality of motor behavior which may involve particular forms of stupor, rigidity, excitement or inappropriate posture.

An obsolete concept, historically used for childhood mental disorders thought to be a form of schizophrenia.

Misunderstanding among individuals, frequently research subjects, of scientific methods such as randomization and placebo controls.

An effect usually, but not necessarily, beneficial that is attributable to an expectation that the regimen will have an effect, i.e., the effect is due to the power of suggestion.

More From BioPortfolio on "Telmisartan as an Adjunctive Treatment for Metabolic Problems in Patients With Schizophrenia"

Advertisement
Quick Search
Advertisement
Advertisement

 

Relevant Topics

Psychiatry
Psychiatry is the study of mental disorders and their diagnosis, management and prevention.  Conditions include schizophrenia, severe depression and panic disorders among others. There are pharmaceutical treatments as well as other therapies to help...

Food
Food is any substance consumed to provide nutritional support for the body. It is usually of plant or animal origin, and contains essential nutrients, such as carbohydrates, fats, proteins, vitamins, or minerals. The substance is ingested by an organism ...


Searches Linking to this Trial