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

Phase 4

Terminated

• Conditions: Schizophrenia; Schizoaffective Disorder
• Interventions: Drug: Amantadine Hydrochloride, USP; Drug: Placebo

• Registration Number: NCT00975611
• Lead Sponsor: David C. Henderson, MD

Brief 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.

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 Timeline

• Study First Submitted: 2009-09-10
• Study First Submitted QC: 2009-09-10
• Study First Posted: 2009-09-11
• Study Start: 2009-10
• Primary Completion: 2012-01
• Study Completion: 2012-01
• Status Verified: 2013-01
• Results First Submitted: 2013-01-28
• Results First Submitted QC: 2013-05-03
• Last Update Submitted: 2013-05-03
• Results First Posted: 2013-06-10
• Last Update Posted: 2013-06-10

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 6

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Amantadine 100mg BID	Amantadine Hydrochloride, USP	Subjects take amantadine 100mg tablets twice per day (BID)
Amantadine, 200mg BID	Amantadine Hydrochloride, USP	Subjects take amantadine 200mg tablets twice per day (BID)
Amantadine, placebo BID	Placebo	Subjects take placebo tablets twice per day (BID)

Primary Outcome Measures

Name	Time	Method
Change in Prolactin Levels for Individuals Treated With Adjunctive Amantadine Versus Placebo.	week 4 and week 8

Trial Locations

Locations (1)

Freedom Trail Clinic; 🇺🇸 Boston, Massachusetts, United States