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

Study Overview
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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.

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.

Official Title
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Amantadine Addition to Paliperidone ER or Risperidone Consta Therapy for Prolactin Elevation

Conditions
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Schizophrenia, Schizoaffective Disorder

Intervention / Treatment
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* Drug: Amantadine Hydrochloride, USP
* Drug: Amantadine Hydrochloride, USP
* Drug: Placebo


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Amantadine 100mg BID<br>Subjects take amantadine 100mg tablets twice per day (BID) | Drug: Amantadine Hydrochloride, USP<br>* amantadine tablets 100 mg. BID for 4 weeks<br>* Other names: Symmetrel;|
| Active Comparator: Amantadine, 200mg BID<br>Subjects take amantadine 200mg tablets twice per day (BID) | Drug: Amantadine Hydrochloride, USP<br>* amantadine 200 mg. tablets BID for 4 weeks<br>* Other names: Symmetrel;|
| Placebo Comparator: Amantadine, placebo BID<br>Subjects take placebo tablets twice per day (BID) | Drug: Placebo<br>* tablets BID, for 4 weeks<br>* Other names: Symmetrel placebo;|

What is the study measuring?
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Primary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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schizophrenia, schizoaffective disorder, paliperidone ER, risperidone Consta, prolactin, hyperprolactinemia