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NCT00595504 · ClinicalTrials.gov registry record · Phase 4
Ramelteon as an Adjunct Therapy in Non-Diabetic Patients With Schizophrenia
A Phase 4 study of Schizophrenia and Schizoaffective Disorder, sponsored by Massachusetts General Hospital.
- Completed
- Registry status
- Phase 4
- Development phase
- 25
- Enrollment target
- 1
- Study location
NCT00595504: Completed Phase 4 study of Schizophrenia and Schizoaffective Disorder, sponsored by Massachusetts General Hospital.
NCT00595504 is a Phase 4 study of Schizophrenia and Schizoaffective Disorder that has completed, run by Massachusetts General Hospital. The registered enrollment target is 25 participants, below the 219-participant average among 315 other Schizophrenia trials with a reported enrollment target (89% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00595504, a Phase 4 study of Schizophrenia and Schizoaffective Disorder, has completed, sponsored by Massachusetts General Hospital.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 25 participants
- Enrollment target
- 1
- Study location
Study 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.
Primary Outcome
A comparison between the ramelteon group and the placebo group in change in waist circumference (measured in cm) measured at Baseline and Week 8.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Ramelteon
Study Locations (1)
Massachusetts
- Freedom Trail Clinic - Boston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 25 participants |
| Start Date | 2008-01 |
| Est. Completion | 2010-03 |
| Phase | Phase 4 |
What the finished NCT00595504 record still lists
NCT00595504 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 25 participants, a relatively small participant target, below the 219-participant average among 315 other Schizophrenia trials with a reported enrollment target (89% lower).
The record links to 3 conditions, with Schizophrenia appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT00595504 reports a single indexed study location in Massachusetts.
Frequently Asked Questions
What is clinical trial NCT00595504 about?
NCT00595504 is a clinical study titled "Ramelteon as an Adjunct Therapy in Non-Diabetic Patients With Schizophrenia". 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 happen...
What is the current status of trial NCT00595504?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 25 participants. The study started on 2008-01. Estimated completion is 2010-03.
What conditions does trial NCT00595504 study?
This clinical trial studies the following conditions: Schizophrenia, Schizoaffective Disorder, Schizophreniform Disorders.
What interventions are being tested in trial NCT00595504?
The interventions under investigation include: Placebo (DRUG), Ramelteon (DRUG).
Who is sponsoring clinical trial NCT00595504?
This trial is sponsored by Massachusetts General Hospital, which has 2,032 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00595504 being conducted?
This trial has 1 study location across Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Schizophrenia
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT00595504's enrollment target sits among peer trials
25 272nd of 315 higher than 41 of 315 other Schizophrenia trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Schizophrenia trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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