Clinical Trial: Evaluating Extended-Release (ER) OROS Paliperidone Versus Placebo on Sleep in Schizophrenia Subjects

This study is currently recruiting patients.

Sponsored by: Johnson & Johnson Pharmaceutical Research and Development, L.L.C.
Information provided by: Johnson & Johnson Pharmaceutical Research and Development, L.L.C.

Purpose

This trial is a multicenter, double-blind, randmomized, placebo-controlled study in subjects with schizophrenia and schizophrenia related insomnia.

The primary objective of this study is to evaluate the amelioration of the sleep architecture of subjects with schizophrenia and schizophrenia-related insomnia, treated with either 9 mg of extended-release (ER) OROS paliperidone or placebo, using polysomnography.

Condition Treatment or Intervention Phase
Schizophrenia
Insomnia
 Drug: ER Oros paliperidone
Phase II

MedlinePlus related topics:  Schizophrenia;   Sleep Disorders

Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Placebo Control

Official Title: A Double-Blind, Placebo-Controlled, Randomized Study Evaluating the effect of ER OROS Paliperidone Compared with Placebo on Sleep Architecture in Subjects with Schizophrenia

Eligibility

Ages Eligible for Study:  18 Years   -   45 Years,  Genders Eligible for Study:  Both

Criteria

Inclusion Criteria:

  • Diagnosed with schizophrenia and schizophrenia-related insomnia, no relapse or psychosis for at least 3 months before screening, and considered symptomatically stable
  • Apnea/hypopnea
  • Weigh >/= 50 kg (>/=110 lbs), with a BMI >/= 18 and </= 35 kg/m2, inclusive
  • If female, must be postmenopausal for at least 2 years, surgically sterile, abstinent, or agree to practice an effective method of birth control if they are sexually active before entry and throughout the study.
  • Must have signed an informed consent document
  • Agree to not use alcohol or medication, prescription or nonprescription, including vitamins/herbals
  • Agree to follow caffeine/methylxanthine (including chocolate)/smoking restrictions during the study and agree to eat standardized meals
  • Agree to adhere to sleep schedule
  • Agree to refrain from any strenuous physical activity
  • Have a sleep history of a minimum of 1.5 hours of wakefulness out of 8 hours in bed

Exclusion Criteria:

  • Current history of suicidal or violent behavior or have exhibited this behavior within the past 6 months
  • Diagnosis of primary insomnia
  • Unstable blood pressure
  • Have sleep problems related to general medical conditions, or substance abuse
  • Diagnosis of or evidence of narcolepsy
  • Unable to swallow the study medication whole with the aid of water
  • Preexisting severe gastrointestinal narrowing
  • Female subject who is pregnant
  • Known or suspected history of infection with HIV or hepatitis B or C
  • Received an experimental drug and/or used an experimental medical device within 30 days before randomization
  • Taken tricyclic, selective serotonin reuptake inhibitor or selective norepinephrine uptake inhibitor antidepressants, lithium, mood stabilizers, anticonvulsants, or benzodiazepines within 2 weeks of screening
  • Received monoamine oxidase (MAO) inhibitors within 30 days of screening
  • Known or suspected hypersensitivity or intolerance to risperidone or paliperidone
  • An acute febrile illness within 5 days before randomization
  • Known or suspected allergy to heparin (in case a heparin lock is used for blood sampling)
  • History of significant bleeding diathesis or bleeding tendencies associated with active ulceration or overt bleeding that could preclude multiple venipunctures
  • Blood loss or have donated ≥500 mL of blood within 60 days before randomization
  • Planned surgery during the course of the study
  • Relevant history of any clinically significant and/or unstable cardiovascular, respiratory, neurological (including seizures or significant cerebrovascular), renal, hepatic, endocrine, immunologic, ophthalmologic, hematologic, or other systemic diseases
  • Are employees of the investigator or study center

Location and Contact Information


France
      Centre Hospitalier Spécialisé de Rouffach, Rouffach,  68250,  France; Recruiting
Jean-Paul Macher, M.D.  03 89 78 10 18 
Jean-Paul Macher, MD,  Principal Investigator

      Service de PsychiatrieHôpitaux Universitaires de Strasbourg, Strasbourg,  67000,  France; Recruiting
Michel Patris, PROF.  03 88 11 62 16 62 14    Michel.patris@chru-strasbourg.fr 
Michel Patris, Pr,  Principal Investigator

      C H d’Erstein, Erstein,  67150,  France; Recruiting
Philippe Meyer, MD  03 90 64 20 00 
Philippe Meyer, MD,  Principal Investigator

Poland
      Samodzielny Publiczny Szpital Kliniczny nr 1. Klinika Psychiatrii, Lublin,  20-439,  Poland; Not yet recruiting
Marek Masiak, Prof. dr med.  48 (0)817 441 588 
Marek Masiak, Prof.,  Principal Investigator

      SPP ZOZ im. dr S. Deresza, Choroszcz,  116-070,  Poland; Not yet recruiting
Mariusz Mikulski, Dr.  48 (0)857 191 091 
Mariusz Mikulski, Dr,  Principal Investigator

      Prof. dr hab. n med.Jerzy Landowski, Gdansk,  80-952,  Poland; Not yet recruiting
Jerzy Landowski, Prof  48 (0)583 492 650 
Jerzy Landowski, Prof.,  Principal Investigator

Romania
      Dr. Victoria Burtea, Brasov,  500079,  Romania; Not yet recruiting
Victoria Burtea, Dr  +40 (0)268 415 245 
Victoria Burtea, Dr,  Principal Investigator

      University Clinic of Psychiatry, Craiova,  200317,  Romania; Not yet recruiting
Dragos Marinescu, Prof  40 (0)251 426 161 
Dragos Marinescu, Prof,  Principal Investigator

      Psychiatry and Neurology Hospital, Brasov,  500079,  Romania; Not yet recruiting
Alexandru Grigoriu, Prof  40 (0)268 511 481 
Alexandru Grigoriu, Prof,  Principal Investigator

More Information

Study ID Numbers:  R076477-SCH-1010
Record last reviewed:  March 2005
Last Updated:  March 14, 2005
Record first received:  March 11, 2005
ClinicalTrials.gov Identifier:  NCT00105326
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-04-08


Source: ClinicalTrials.gov
Cache Date: April 9, 2005

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