Ramelteon as an Adjunct Therapy in Non-Diabetic Patients With Schizophrenia

NCT00595504 | Completed Phase 4 Results DMC

• 2 other identifiers: 2007P-001929FWA00003136
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Schizophrenia; Schizoaffective Disorder; Schizophreniform Disorders

Keywords

schizophrenia; metabolism; antipsychotics; diabetes; rozerem

Outcome Measures

Primary Outcomes (3)

• Change in Waist Circumference

  A comparison between the ramelteon group and the placebo group in change in waist circumference (measured in cm) measured at Baseline and Week 8.

  Baseline and Week 8

• Change in Insulin Resistance as Measured by the Homeostatic Model Assessment of Insulin Resistance (HOMA-IR).

  A comparison between the ramelteon group and the placebo group of change in insulin resistance measured by the homeostatic model assessment of insulin resistance (HOMA-IR), assessed at Baseline and Week 8.

  Baseline and Week 8

• Change in Abdominal Fat (DEXA).

  A comparison between the ramelteon group and the placebo group of change in abdominal fat measured by a DEXA scan, assessed at Baseline and Week 8.

  Baseline and Week 8

Study Arms (2)

1

EXPERIMENTAL

Ramelteon 8mg/day

Drug: Ramelteon

2

PLACEBO COMPARATOR

sugar pill

Drug: Placebo

Interventions

Ramelteon DRUG

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.

Also known as: Rozerem

1

Placebo DRUG

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.

2

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:

You may not qualify if:

• 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

Sponsors & Collaborators

• Massachusetts General Hospital: lead
• Takeda: collaborator

Study Sites (1)

Freedom Trail Clinic

Boston, Massachusetts, 02114, United States

Location

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MeSH Terms

Conditions

Schizophrenia; Psychotic Disorders; Diabetes Mellitus

Interventions

ramelteon

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Limitations and Caveats

The limitations of this study include the relatively small sample size and short intervention period (8 weeks).

Results Point of Contact

• Title: David C. Henderson, M.D.
• Organization: Massachusetts General Hospital

dchenderson@partners.org

617-912-7800

Study Officials

• David C. Henderson, M.D.

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Psychiatry

Study Record Dates

• First Submitted: January 7, 2008
• First Posted: January 16, 2008
• Study Start: January 1, 2008
• Primary Completion: March 1, 2010
• Study Completion: March 1, 2010
• Last Updated: September 13, 2012
• Results First Posted: September 13, 2012

Record last verified: 2012-08

Locations

US (1)