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

Sponsor:	David C. Henderson, MD
Collaborator:	Ortho-McNeil Janssen Scientific Affairs, LLC
Information provided by (Responsible Party):	David C. Henderson, MD, 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:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment
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: Weeks 4 and 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:	December 2011
Estimated Primary Completion Date:	December 2011 (Final data collection date for primary outcome measure)

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

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: Claire Oppenheim	617-912-7837	coppenheim@partners.org
Contact: Leah Briggs	617-912-7848	lbriggs@partners.org

Locations

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

Sponsors and Collaborators

David C. Henderson, MD

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:	David C. Henderson, MD, Associate Professor, North Suffolk Mental Health Association
ClinicalTrials.gov Identifier:	NCT00975611 History of Changes
Other Study ID Numbers:	R076477PD14002
Study First Received:	September 10, 2009
Last Updated:	October 17, 2011
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:

Psychotic Disorders
Schizophrenia
Schizophrenia and Disorders with Psychotic Features
Mental Disorders
Amantadine
Risperidone
9-hydroxy-risperidone
Antiparkinson Agents
Anti-Dyskinesia Agents
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Antiviral Agents
Anti-Infective Agents
Dopamine Agents

Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Serotonin Antagonists
Serotonin Agents
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Dopamine Antagonists

ClinicalTrials.gov processed this record on February 09, 2012