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
  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:


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
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

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
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:
Psychotic Disorders
Schizophrenia
Mental Disorders
Schizophrenia and Disorders with Psychotic Features
9-hydroxy-risperidone
Amantadine
Risperidone
Analgesics
Analgesics, Non-Narcotic
Anti-Dyskinesia Agents
Anti-Infective Agents
Antiparkinson Agents
Antipsychotic Agents
Antiviral Agents
Central Nervous System Agents
Central Nervous System Depressants
Dopamine Agents
Dopamine Antagonists
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Psychotropic Drugs
Sensory System Agents
Serotonin Agents
Serotonin Antagonists
Therapeutic Uses
Tranquilizing Agents

ClinicalTrials.gov processed this record on October 30, 2014