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

NCT00975611 · Status: TERMINATED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 6

Last updated 2013-06-10

Study results available
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Summary

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.

Conditions

Interventions

DRUG

Amantadine Hydrochloride, USP

amantadine tablets 100 mg. BID for 4 weeks

DRUG

Amantadine Hydrochloride, USP

amantadine 200 mg. tablets BID for 4 weeks

DRUG

Placebo

tablets BID, for 4 weeks

Sponsors & Collaborators

  • Ortho-McNeil Janssen Scientific Affairs, LLC

    collaborator INDUSTRY

  • David C. Henderson, MD

    lead OTHER

Principal Investigators

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

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-10-31
Primary Completion
2012-01-31
Completion
2012-01-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00975611 on ClinicalTrials.gov