Study of Amantadine for Risperidone Consta or Paliperidone Treated Patients to Decrease Prolactin Elevation

This study has been terminated.
(The sponsor withdrew support due to slow accrual of eligible subjects.)
Sponsor:
Collaborator:
Ortho-McNeil Janssen Scientific Affairs, LLC
Information provided by (Responsible Party):
David C. Henderson, MD, North Suffolk Mental Health Association
ClinicalTrials.gov Identifier:
NCT00975611
First received: September 10, 2009
Last updated: May 3, 2013
Last verified: January 2013

September 10, 2009
May 3, 2013
October 2009
January 2012   (final data collection date for primary outcome measure)
Change in Prolactin Levels for Individuals Treated With Adjunctive Amantadine Versus Placebo. [ Time Frame: week 4 and week 8 ] [ Designated as safety issue: Yes ]
To assess prolactin levels at 4 weeks for individuals treated with adjunctive amantadine or placebo. [ Time Frame: Week 4 and week 8 ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT00975611 on ClinicalTrials.gov Archive Site
Not Provided
Examine the efficacy of amantadine in reducing prolactin-related side effects. Examine the efficacy of amantadine in improving tardive dyskinesia. Examine the effects of amantadine on weight, fasting glucose and lipids. [ Time Frame: Weeks 2,4,8 ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
 
Study of Amantadine for Risperidone Consta or Paliperidone Treated Patients to Decrease Prolactin Elevation
Amantadine Addition to Paliperidone ER or Risperidone Consta Therapy for Prolactin Elevation

The purpose of this study is to show that amantadine might help to reduce the side effect of the medications which are prescribed to treat schizophrenia or schizoaffective disorder. High level of hormone prolactin, or hyperprolactinemia, is one of the side effects which might be developed in patients treated with the paliperidone ER or risperidone Consta.

High level of prolactin might stimulate breast development, might decrease sexual desire (libido). The goals of this study are to demonstrate that amantadine lowers prolactin levels, decreases side effects, and improves psychiatric symptoms.

Trial Description: A double-blind, placebo-controlled, prospective, randomized trial to evaluate the effects of two doses of amantadine or placebo in the management of antipsychotic-induced hyperprolactinemia and psychiatric status in patients with schizophrenia or schizoaffective disorder who are clinically stable on paliperidone ER or risperidone Consta. Placebo or amantadine 100 mg or 200 mg BID will be administered to participants for 4 consecutive weeks as an adjunctive therapy in 72 schizophrenia subjects treated with paliperidone or risperidone Consta to examine amantadine effects on fasting AM serum prolactin levels. Participants will be followed after suspension of amantadine or placebo for an additional 4 weeks for safety purposes. The goals of this study are to prospectively demonstrate that amantadine lowers prolactin levels, and evaluate the impact of amantadine on psychiatric symptoms, and on prolactin-related side effects in patients treated with paliperidone ER or risperidone Consta.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Schizophrenia
  • Schizoaffective Disorder
  • Drug: Amantadine Hydrochloride, USP
    amantadine tablets 100 mg. BID for 4 weeks
    Other Name: Symmetrel
  • Drug: Amantadine Hydrochloride, USP
    amantadine 200 mg. tablets BID for 4 weeks
    Other Name: Symmetrel
  • Drug: Placebo
    tablets BID, for 4 weeks
    Other Name: Symmetrel placebo
  • Active Comparator: Amantadine 100mg BID
    Subjects take amantadine 100mg tablets twice per day (BID)
    Intervention: Drug: Amantadine Hydrochloride, USP
  • Active Comparator: Amantadine, 200mg BID
    Subjects take amantadine 200mg tablets twice per day (BID)
    Intervention: Drug: Amantadine Hydrochloride, USP
  • Placebo Comparator: Amantadine, placebo BID
    Subjects take placebo tablets twice per day (BID)
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
6
January 2012
January 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Male or female
  • Age 18-65 years
  • Diagnosis of schizophrenia, schizoaffective disorder, any subtype or schizophreniform disorder
  • Well established compliance with out-patient medications including paliperidone ER or risperidone Consta for 3 months

Exclusion Criteria:

  • Current substance or alcohol abuse
  • Significant medical illness
  • Women who are pregnant, breastfeeding, or who are unwilling or unable to use an effective form of birth control during the entire study
  • Subjects treated with more than one antipsychotic drug
Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00975611
R076477PD14002
No
David C. Henderson, MD, North Suffolk Mental Health Association
David C. Henderson, MD
Ortho-McNeil Janssen Scientific Affairs, LLC
Principal Investigator: David C. Henderson, M.D. North Sufflok Mental Health Association, Freedom Trail Clinic
North Suffolk Mental Health Association
January 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP