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

Schizophrenia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00975611
• Other study ID #: R076477PD14002
• Status: Terminated
• Phase: Phase 4
• First received: September 10, 2009
• Last updated: May 3, 2013
• Start date: October 2009
• Est. completion date: January 2012

Study information

• Verified date: January 2013
• Source: North Suffolk Mental Health Association
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 6
• Est. completion date: January 2012
• Est. primary completion date: January 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

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

Related Conditions & MeSH terms

• Psychotic Disorders
• Schizoaffective Disorder
• Schizophrenia

Intervention

Drug:
• Amantadine Hydrochloride, USP
amantadine tablets 100 mg. BID for 4 weeks
• Amantadine Hydrochloride, USP
amantadine 200 mg. tablets BID for 4 weeks
• Placebo
tablets BID, for 4 weeks

Locations

Country	Name	City	State
United States	Freedom Trail Clinic	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
David C. Henderson, MD	Ortho-McNeil Janssen Scientific Affairs, LLC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Prolactin Levels for Individuals Treated With Adjunctive Amantadine Versus Placebo.		week 4 and week 8	Yes