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Study in Stabilized Schizophrenic Patients to Evaluate the Pharmacokinetics of Risperidone and 9-Hydroxy (OH)-Risperidone When Risperidone is Administered From a Polyurethane Implant

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01774435
Recruitment Status : Completed
First Posted : January 24, 2013
Last Update Posted : November 3, 2014
Information provided by (Responsible Party):
Endo Pharmaceuticals

Brief Summary:
This is an study evaluating the safety, tolerability, and PK of EN3342 in implantation durations of 6 months.

Condition or disease Intervention/treatment Phase
Schizophrenia Drug: EN3342 Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 35 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1, Open-Label, Study in Stabilized Schizophrenic Patients to Evaluate the Pharmacokinetics of Risperidone and 9-Hydroxy (OH) Risperidone When Risperidone is Administered From a Polyurethane Implant
Study Start Date : October 2012
Actual Primary Completion Date : October 2013
Actual Study Completion Date : October 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Schizophrenia
Drug Information available for: Risperidone

Arm Intervention/treatment
Experimental: EN3342
EN3342 (risperidone) subcutaneous implant
Drug: EN3342

Primary Outcome Measures :
  1. PK parameters (Cmax and AUC) for active moiety, 9-OH-risperidone and risperidone [ Time Frame: 6 months ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Subject Inclusion Criteria

  1. Subject (and/or a subject's authorized legal representative) has provided written informed consent
  2. Subject has identified a caregiver or personal contact with whom the subject has significant contact with at least once per week
  3. Subject is male or female of non-child bearing potential between 18 to 60 years of age inclusive
  4. Subject has a diagnosis of schizophrenia according to DSM-IV criteria
  5. Subject has a body mass index (BMI) ≥18.5 and ≤35.0 kg/m2
  6. Subject is assessed to be symptomatically stable by the Investigator, with regard to his or her psychiatric condition
  7. Subject is assessed by the Investigator to be symptomatically stable with regard to pre existing medical conditions as evidenced by medical history, clinically significant findings on physical examination, vital signs, clinical laboratory evaluations (hematology, serum chemistries, and urinalysis) or 12-lead electrocardiogram (ECG). Subjects may continue on their current medication regimen to control pre-existing medical and psychiatric (other than schizophrenia) conditions including the use of PRN medications.
  8. Subject is currently stable on a 4-, 6-, or 8-mg oral dose of risperidone for 30 days prior to admission

Subject Exclusion Criteria

  1. Known hypersensitivity or allergy to lidocaine or any local anesthetic agent of the amide type (local anesthetic used during implant and explant procedures)
  2. Known sensitivity to polyurethane
  3. Hospitalized or required acute crisis intervention for symptom exacerbation in the 30 days prior to admission as determined by the Investigator
  4. Subject has a history of suicide attempt in the last year, or in the opinion of the investigator is currently at imminent risk of suicide
  5. Reports or reveals a presence of clinically significant skin disorders (such as, but not limited to, skin cancer, psoriasis, eczema, or atopic dermatitis), evidence of recent sunburn, scar tissue, tattoo, open sore, body piercing or branding at the intended implantation site that would interfere with the implantation procedure or interfere with implant site assessments as determined by the Investigator
  6. History of abnormal scar formation or family history of keloid formation
  7. Have a positive screen for substances of abuse conducted at screening or had any history of abuse in the last six months as defined by DSM-IV criteria
  8. Have impaired hepatic (ALT/AST >1.5 times higher than the upper limit of normal) or renal function (eGFR <50mL/min)
  9. Previously defined hypersensitivity to risperidone
  10. History of neuromalignant syndrome (NMS)
  11. Electroconvulsive therapy within 6 months of admission
  12. Treatment of coexisting medical conditions that require the introduction of cytochrome P450 2D6 inhibitors or inducers
  13. Positive screen for Hepatitis B Surface Antigen (HBsAg), Hepatitis C Antibody (anti HCV), or human immunodeficiency virus (HIV) antibody and/or antigen
  14. Participation in the treatment phase of a clinical study or receipt of an investigational drug within 30 days prior to study drug administration on Day 1; for investigational drugs with an elimination half-life greater than 15 days, this time period will be extended to 60 days
  15. Prior participation in a EN3342 study
  16. Involvement in the planning and/or conduct of the study (applies to both Endo staff or staff at the investigational site)
  17. History of difficulty with phlebotomy procedures

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01774435

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United States, New Jersey
CRI Lifetree
Marlton, New Jersey, United States
Sponsors and Collaborators
Endo Pharmaceuticals
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Principal Investigator: Robert Litman, MD CBH Health LLC
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Responsible Party: Endo Pharmaceuticals Identifier: NCT01774435    
Other Study ID Numbers: EN3342-102
First Posted: January 24, 2013    Key Record Dates
Last Update Posted: November 3, 2014
Last Verified: October 2014
Keywords provided by Endo Pharmaceuticals:
Stable Schizophrenic
Additional relevant MeSH terms:
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Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders