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

May 3, 2013 updated by: David C. Henderson, MD

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

6

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02459
        • Freedom Trail Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 61 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Amantadine 100mg BID
Subjects take amantadine 100mg tablets twice per day (BID)
Drug: Amantadine Hydrochloride, USP
amantadine tablets 100 mg. BID for 4 weeks
Other Names:
  • Symmetrel
Drug: Amantadine Hydrochloride, USP
amantadine 200 mg. tablets BID for 4 weeks
Other Names:
  • Symmetrel
Active Comparator: Amantadine, 200mg BID
Subjects take amantadine 200mg tablets twice per day (BID)
Drug: Amantadine Hydrochloride, USP
amantadine tablets 100 mg. BID for 4 weeks
Other Names:
  • Symmetrel
Drug: Amantadine Hydrochloride, USP
amantadine 200 mg. tablets BID for 4 weeks
Other Names:
  • Symmetrel
Placebo Comparator: Amantadine, placebo BID
Subjects take placebo tablets twice per day (BID)
Drug: Placebo
tablets BID, for 4 weeks
Other Names:
  • Symmetrel placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in Prolactin Levels for Individuals Treated With Adjunctive Amantadine Versus Placebo.
Time Frame: week 4 and week 8
week 4 and week 8

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

David C. Henderson, MD

Collaborators

Ortho-McNeil Janssen Scientific Affairs, LLC

Investigators

  • Principal Investigator: David C. Henderson, M.D., North Sufflok Mental Health Association, Freedom Trail Clinic

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2009

Primary Completion (Actual)

January 1, 2012

Study Completion (Actual)

January 1, 2012

Study Registration Dates

First Submitted

September 10, 2009

First Submitted That Met QC Criteria

September 10, 2009

First Posted (Estimate)

September 11, 2009

Study Record Updates

Last Update Posted (Estimate)

June 10, 2013

Last Update Submitted That Met QC Criteria

May 3, 2013

Last Verified

January 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • R076477PD14002

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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