Telmisartan Pilot Study on Treatment Resistant Schizophrenia
Condition: Schizophrenia; Schizo Affective Disorder; Treatment-resistant Schizophrenia
MeSH terms: Schizophrenia; Mood Disorders; Schizophrenia, Treatment-Resistant; Psychotic Disorders
Intervention: Telmisartan Pill
Intervention description: 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.
Intervention MeSH terms: Telmisartan
Phase: Phase 2
Study type: Interventional
Primary purpose: Other
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 6.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No

Summary:

      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.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age 18-65 years inclusive.

          -  Primary diagnosis of Schizophrenia or Schizoaffective Disorder established by a
             structured psychiatric evaluation (MINI) based on Diagnostic and Statistical Manual of
             Mental Disorders Fifth Edition (DSM-V) criteria.

          -  A Positive and Negative Syndrome Scale (PANSS) (Kay et al 1987) total score ≥ 70 with
             a score of > 4 on two or more of the following PANSS items: delusions, conceptual
             disorganization, hallucinatory behavior, suspiciousness, and unusual thought content.

          -  A score of ≥4 on the Clinical Global Impression-Severity (CGI-S) (Guy, 1976).

          -  Must have ongoing antipsychotic treatment for at least 8 weeks, with a stable dose for
             at least 4 weeks. Subjects who have failed to achieve clinically-recognized symptom
             reduction to at least 1 marketed antipsychotic agent at a therapeutic dose for ≥ 8
             weeks during the past 12 months, will be eligible.

          -  Women of childbearing potential must have a negative pregnancy test performed at
             screening visit prior to receiving the study medication. Women enrolled in this trial
             must use single barrier contraception.

        Exclusion Criteria:

          -  Psychiatrically unstable.

          -  Subjects with any clinically significant abnormalities as determined by medical
             history, physical exam, clinical and lab evaluation suggestive of an underlying
             disease state that may, in the opinion of the investigator, confound the results of
             study, increase risk to the subject, or lead to difficulty complying with the study
             plan.

          -  Current insulin treatment for diabetes.

          -  History of immunosuppression.

          -  Current or recent radiation or chemotherapy treatment for cancer.

          -  Chronic use of steroids (except local use or inhaler).

          -  Pregnancy or breastfeeding.

          -  Women who are planning to become pregnant.

          -  Use of diuretics, ACE inhibitors, spironolactone, potassium supplements, digoxin or
             warfarin because the possible drug-drug interaction with telmisartan.

          -  Tested positive for the urine drug screen.

          -  Subjects at imminent risk of suicide or injury to self or others, as per the opinion
             of the investigator, or history of significant suicide attempt within the last 6
             months as per the Columbia Suicide Severity Rating Scale (C-SSRS).

          -  Subjects that have taken an investigational drug or taken part in a clinical trial
             within 30 days prior to screening.

          -  Subjects with a current (within the last 3 months) DSM-V diagnosis of alcohol or
             substance use disorder (excluding nicotine and caffeine) as established by the
             clinical assessment (MINI) at the screening visit will be excluded.

          -  Any other reason that, in the opinion of the investigator, would compromise patient
             safety or integrity of the study.

          -  Subjects with the lab values defined as exclusionary safety values.