Study of Amantadine for Risperidone Treated Patients to Decrease Prolactin Elevation - Full Text View

Sponsor:	North Suffolk Mental Health Association
Collaborator:	Ortho-McNeil Janssen Scientific Affairs, LLC
Information provided by:	North Suffolk Mental Health Association
ClinicalTrials.gov Identifier:	NCT00975611

Purpose

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.

Condition	Intervention	Phase
Schizophrenia Schizoaffective Disorder	Drug: Amantadine Hydrochloride, USP Drug: Placebo	Phase IV

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Amantadine Addition to Paliperidone ER or Risperidone Consta Therapy for Prolactin Elevation

Resource links provided by NLM:

MedlinePlus related topics: Schizophrenia

Drug Information available for: Amantadine sulfate Risperidone Paliperidone Amantadine hydrochloride Amantadine Prolactin

U.S. FDA Resources

Further study details as provided by North Suffolk Mental Health Association:

Primary Outcome Measures:

To assess prolactin levels at 4 weeks for individuals treated with adjunctive amantadine or placebo. [ Time Frame: Week 4 and week 8 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

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. [ Time Frame: Weeks 2,4,8 ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	72
Study Start Date:	October 2009
Estimated Study Completion Date:	September 2011
Estimated Primary Completion Date:	July 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Amantadine 100mg BID: Active Comparator	Drug: Amantadine Hydrochloride, USP amantadine tablets 100 mg. BID for 4 weeks
Amantadine, 200mg: Active Comparator	Drug: Amantadine Hydrochloride, USP amantadine 200 mg. tablets BID for 4 weeks
Amantadine, placebo: Placebo Comparator	Drug: Placebo tablets BID, for 4 weeks

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

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00975611

Contacts

Contact: Alex Paiva	617-912-7837	apaiva1@partners.org
Contact: Karina Tsatourian, PH.D.	617-912-7882	ktsatourian@partners.org

Locations

United States, Massachusetts
Freedom Trail Clinic
Boston, Massachusetts, United States, 02459

Sponsors and Collaborators

North Suffolk Mental Health Association

Ortho-McNeil Janssen Scientific Affairs, LLC

Investigators

Principal Investigator:

David C. Henderson, M.D.

North Sufflok Mental Health Association, Freedom Trail Clinic

More Information

No publications provided

Responsible Party:	North Suffolk Mental Health Association, Freedom Trail Clinic ( David C. Henderson, M.D. Associate Professor of Psychiatry, Harvard Medical School. Associate Director, Schizophrenia Program, Massachisetts General Hospital )
Study ID Numbers:	R076477PD14002
Study First Received:	September 10, 2009
Last Updated:	September 11, 2009
ClinicalTrials.gov Identifier:	NCT00975611 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by North Suffolk Mental Health Association:

schizophrenia
schizoaffective disorder
paliperidone ER

risperidone Consta
prolactin
hyperprolactinemia

Additional relevant MeSH terms:

Anti-Infective Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Anti-Dyskinesia Agents
Physiological Effects of Drugs
Psychotropic Drugs
Antiparkinson Agents
9-hydroxy-risperidone
Schizophrenia
Serotonin Antagonists
Pathologic Processes
Mental Disorders
Sensory System Agents
Therapeutic Uses
Psychotic Disorders

Analgesics
Schizophrenia and Disorders with Psychotic Features
Tranquilizing Agents
Disease
Risperidone
Central Nervous System Depressants
Dopamine Antagonists
Antipsychotic Agents
Antiviral Agents
Pharmacologic Actions
Serotonin Agents
Analgesics, Non-Narcotic
Dopamine Agents
Peripheral Nervous System Agents
Amantadine

ClinicalTrials.gov processed this record on February 08, 2010