Study of Amantadine for Risperidone Consta or Paliperidone Treated Patients to Decrease Prolactin Elevation
Information source: North Suffolk Mental Health Association
ClinicalTrials.gov processed this data on August 23, 2015
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
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
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.
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: Change in Prolactin Levels for Individuals Treated With Adjunctive Amantadine Versus Placebo.
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.
Minimum age: 18 Years.
Maximum age: 65 Years.
- Male or female
- Age 18-65 years
- Diagnosis of schizophrenia, schizoaffective disorder, any subtype or schizophreniform
- Well established compliance with out-patient medications including paliperidone ER
or risperidone Consta for 3 months
- 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
Freedom Trail Clinic, Boston, Massachusetts 02459, United States
Starting date: October 2009
Last updated: May 3, 2013