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

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE4

Total Enrollment

6 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-10-31

Study Completion Date

2012-01-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Schizophrenia Schizoaffective Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Amantadine 100mg BID

Subjects take amantadine 100mg tablets twice per day (BID)

Group Type ACTIVE_COMPARATOR

Amantadine Hydrochloride, USP

Intervention Type DRUG

amantadine tablets 100 mg. BID for 4 weeks

Amantadine, 200mg BID

Subjects take amantadine 200mg tablets twice per day (BID)

Group Type ACTIVE_COMPARATOR

Amantadine Hydrochloride, USP

Intervention Type DRUG

amantadine 200 mg. tablets BID for 4 weeks

Amantadine, placebo BID

Subjects take placebo tablets twice per day (BID)

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

tablets BID, for 4 weeks

Interventions

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Amantadine Hydrochloride, USP

amantadine tablets 100 mg. BID for 4 weeks

Intervention Type DRUG

Amantadine Hydrochloride, USP

amantadine 200 mg. tablets BID for 4 weeks

Intervention Type DRUG

Placebo

tablets BID, for 4 weeks

Intervention Type DRUG

Other Intervention Names

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Symmetrel Symmetrel Symmetrel placebo

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No