Ramelteon as an Adjunct Therapy in Non-Diabetic Patients With Schizophrenia
Condition: Schizophrenia; Schizoaffective Disorder; Schizophreniform Disorders
MeSH terms: Schizophrenia; Psychotic Disorders
Intervention: Ramelteon; Placebo
Intervention description: Two week supply of ramelteon 8mg/day first dispensed at baseline. New two week supply of study medication dispensed at each biweekly visit for 8 consecutive weeks.; Two week supply of placebo tablets first dispensed at baseline. New two week supply of placebo dispensed at each biweekly visit for 8 consecutive weeks.
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 25.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: schizophrenia; metabolism; antipsychotics; diabetes; rozerem

Summary:

      This study involves people who have schizophrenia or schizoaffective disorder who are
      currently taking antipsychotic medications. Some antipsychotic medications may cause weight
      gain and may increase the risk of diabetes mellitus and heart disease.The purpose of this
      study is to find out what happens if another medication (ramelteon) is used along with your
      antipsychotic medication. We want to find out whether doing this will:

        -  Change the way your body breaks down fat and sugar.

        -  Affect your waist size, stomach fat and triglycerides (a type of fat in your blood).

        -  Improve how your body responds to insulin.

        -  Affect your quality of sleep.

        -  Reduce movement disturbances Ramelteon is approved by the U.S. Food and Drug
           Administration (FDA) to treat people that have difficulty falling asleep. It is not
           approved for such things as affecting waist size or improving how the body breaks down
           fat and sugar. Its use in this study is investigational.
    

Eligibility criteria:

        Inclusion Criteria:

          -  diagnosis of schizophrenia, schizoaffective disorder, any subtype or schizophreniform
             disorder

          -  male or female, age 18-65 years

          -  treatment with clozapine, olanzapine, quetiapine or risperidone

          -  well established compliance with medications

          -  Body Mass Index (BMI) of > 27 Kg/m² with any component of metabolic syndrome or
             insulin resistance or a BMI of > 30 Kg/m²:

        Exclusion Criteria:

          -  inability to provide informed consent

          -  substance and alcohol abuse

          -  significant medical illness, including congestive heart failure, severe hepatic
             impairment, severe Chronic Obstructive Pulmonary Disease (COPD), severe sleep apnea,
             severe cardiovascular disease or renal disease

          -  current history of diabetes mellitus or thyroid disease

          -  women who are pregnant, breastfeeding, or who are unwilling or unable to use an
             effective form of birth control during the entire study

          -  psychiatrically unstable, patients with major depression

          -  patients treated with medications known to affect glucose tolerance such as birth
             control pills containing norgestrel, steroids, beta blockers, anti-inflammatory drugs
             (including daily aspirin and ibuprofen), thiazide diuretics; and agents that induce
             weight loss will be excluded from the study

          -  treatment with fluvoxamine in the or ketoconazole past two weeks

          -  treatment with fluconazole (a strong CYP2C9 inhibitor).

          -  subjects treated with ziprasidone and aripiprazole conventional agents

          -  treatment with sedative-hypnotics such as barbiturates, zolpidem, eszopiclone,
             zaleplon. The use of stable daily doses of benzodiazepines is allowed.

          -  known hypersensitivity to ramelteon or any of its components