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

This study has been terminated.

(The sponsor withdrew support due to slow accrual of eligible subjects.)

Sponsor:

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

First received: September 10, 2009

Last updated: May 3, 2013

Last verified: January 2013

History of Changes

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 4


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:

Genetics Home Reference related topics: schizophrenia

MedlinePlus related topics: Schizophrenia

Drug Information available for: Amantadine hydrochloride Amantadine Prolactin Risperidone Paliperidone

Genetic and Rare Diseases Information Center resources: Galactorrhoea-Hyperprolactinaemia

U.S. FDA Resources

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

Primary Outcome Measures:

Change in Prolactin Levels for Individuals Treated With Adjunctive Amantadine Versus Placebo. [ Time Frame: week 4 and week 8 ] [ Designated as safety issue: Yes ]


Enrollment:	6
Study Start Date:	October 2009
Study Completion Date:	January 2012
Primary Completion Date:	January 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: Amantadine 100mg BID Subjects take amantadine 100mg tablets twice per day (BID)	Drug: Amantadine Hydrochloride, USP amantadine tablets 100 mg. BID for 4 weeks Other Name: Symmetrel
Active Comparator: Amantadine, 200mg BID Subjects take amantadine 200mg tablets twice per day (BID)	Drug: Amantadine Hydrochloride, USP amantadine 200 mg. tablets BID for 4 weeks Other Name: Symmetrel
Placebo Comparator: Amantadine, placebo BID Subjects take placebo tablets twice per day (BID)	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 (Adult)
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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations


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

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


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
Results First Received:	January 28, 2013
Last Updated:	May 3, 2013
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:


Schizophrenia Psychotic Disorders Schizophrenia Spectrum and Other Psychotic Disorders Mental Disorders Risperidone Paliperidone Palmitate Amantadine Serotonin Antagonists Serotonin Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Antipsychotic Agents Tranquilizing Agents	Central Nervous System Depressants Psychotropic Drugs Dopamine Antagonists Dopamine Agents Serotonin 5-HT2 Receptor Antagonists Dopamine D2 Receptor Antagonists Antiparkinson Agents Anti-Dyskinesia Agents Antiviral Agents Anti-Infective Agents Analgesics, Non-Narcotic Analgesics Sensory System Agents Peripheral Nervous System Agents

ClinicalTrials.gov processed this record on September 23, 2016

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