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

Information source: North Suffolk Mental Health Association
Information obtained from ClinicalTrials.gov on December 08, 2011
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Schizophrenia; Schizoaffective Disorder

Intervention: Amantadine Hydrochloride, USP (Drug); Amantadine Hydrochloride, USP (Drug); Placebo (Drug)

Phase: Phase 4

Status: Recruiting

Sponsored by: David C. Henderson, MD

Official(s) and/or principal investigator(s):
David C. Henderson, M.D., Principal Investigator, Affiliation: North Sufflok Mental Health Association, Freedom Trail Clinic

Overall contact:
Claire Oppenheim, Phone: 617-912-7837, Email: coppenheim@partners.org

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.

Clinical Details

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

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: To assess prolactin levels at 4 weeks for individuals treated with adjunctive amantadine or placebo.

Secondary outcome: Examine the efficacy of amantadine in reducing prolactin-related side effects. Examine the efficacy of amantadine in improving tardive dyskinesia. Examine the effects of amantadine on weight, fasting glucose and lipids.

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.

Eligibility

Minimum age: 18 Years. Maximum age: 65 Years. Gender(s): Both.

Criteria:

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

Locations and Contacts

Claire Oppenheim, Phone: 617-912-7837, Email: coppenheim@partners.org

Freedom Trail Clinic, Boston, Massachusetts 02459, United States; Recruiting
Claire Oppenheim, Phone: 617-912-7837, Email: coppenheim@partners.org
Leah Briggs, Phone: 617-912-7848, Email: lbriggs@partners.org
Additional Information

Starting date: October 2009
Last updated: October 17, 2011

Page last updated: December 08, 2011

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