NCT00585208 is a Phase 3 clinical trial of Ramelteon in Insomnia, sponsored by Lindner Center of HOPE.

Who is sponsoring NCT00585208?

NCT00585208 is sponsored by Lindner Center of HOPE.

What drugs are being tested in NCT00585208?

Interventions in NCT00585208: Ramelteon, Placebo.

What condition does NCT00585208 study?

NCT00585208 studies Insomnia, Bipolar Disorder.

Is NCT00585208 still recruiting?

NCT00585208 is currently terminated. Last updated 8 May 2013.

Last reviewed 2013-05-08 · How we verify

NCT00585208

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

A Randomized, Double-Blind, Placebo-Controlled Study of Add-On Ramelteon in Ambulatory Bipolar I Disorder With Clinically Significant Sleep Disturbance

Terminated Phase 3 Last updated 8 May 2013

What this trial tests

Phase 3 trial testing Ramelteon in Insomnia in 21 participants. Terminated before completion.

Timeline

1 December 2007

Primary endpoint
1 September 2010

1 December 2010

Quick facts

Lead sponsor	Lindner Center of HOPE
Phase	Phase 3
Status	Terminated
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	21
Start date	1 December 2007
Primary completion	1 September 2010
Estimated completion	1 December 2010
Sites	1 location across United States

Drugs / interventions tested

Ramelteon (RAMELTEON) — full drug profile →
Placebo

Conditions studied

Insomnia — all drugs for Insomnia →
Bipolar Disorder — all drugs for Bipolar Disorder →

Sponsor

Lindner Center of HOPE — full company profile →

Who can join

Adults 18 to 65, any sex, with Insomnia or Bipolar Disorder. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

Pittsburgh Sleep Quality Index (PSQI)
Time frame: 8 weeks
Pittsburgh Insomnia Rating Scale (PIRS)
Time frame: 8 weeks

Sponsor's own description

The purpose of this research study is to evaluate the safety and efficacy of ramelteon (Rozerem™) as an add-on treatment for sleep problems in patients with bipolar disorder. This study will determine whether or not the addition of ramelteon to ongoing medication(s) for bipolar disorder is useful in improving sleep.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.

Verify or expand the search:

Other trials of Ramelteon

Trials testing the same drug.

NCT07382843 — Melatonin Agonist for Shift-time Workers. · Phase 4 · completed
NCT03165695 — Ramelteon vs Placebo for Prevention of Delirium and Improvement of Sleep in Hospitalized Older Adults · Phase 4 · withdrawn
NCT03931070 — The Effect of Ramelteon on Delirium and Sleep in Patients Admitted to the ICU · Phase 4 · completed
NCT03265951 — Ramelteon for Complex Insomnia in Veterans With PTSD · Phase 4 · withdrawn
NCT02669082 — The Exploratory Study to Investigate the Effect of Ramelteon for Insomnia Patients With Major Depressive Disorder by Usi · Phase 4 · completed

Other recruiting trials for Insomnia

Currently open trials in the same condition.

NCT07384429 — Effects of Lemborexant on Motor-sleep Comorbidity in Parkinson's Disease · Phase 4 · recruiting
NCT07270406 — Healthy Behaviors for Insomnia Prevention in People With HIV and Ongoing Pain · NA · recruiting
NCT07071324 — CF Wellness Program · NA · recruiting
NCT07417813 — A Multicenter Observational Study of Lemborexant on Insomnia Patients With Psychiatric Disorders · recruiting
NCT06348082 — Project Women's Insomnia Sleep Health Equity Study (WISHES) · NA · recruiting

Other Lindner Center of HOPE trials

Trials by the same sponsor.

NCT04602936 — Solriamfetol in Binge Eating Disorder · Phase 4 · unknown
NCT03158805 — Saxenda® in Obese or Overweight Patients With Stable Bipolar Disorder (Investigator Initiated) · Phase 2 · completed

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT00585208 (US National Library of Medicine, public domain)
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Lindner Center of HOPE
Last refreshed: 8 May 2013

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT00585208.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing