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

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ClinicalTrials.gov Identifier: NCT00975611
Recruitment Status : Terminated (The sponsor withdrew support due to slow accrual of eligible subjects.)
First Posted : September 11, 2009
Results First Posted : June 10, 2013
Last Update Posted : June 10, 2013
Information provided by (Responsible Party):

Study Description
Brief Summary:

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 or disease Intervention/treatment Phase
Schizophrenia Schizoaffective Disorder Drug: Amantadine Hydrochloride, USP Drug: Placebo Phase 4

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.

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 6 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Amantadine Addition to Paliperidone ER or Risperidone Consta Therapy for Prolactin Elevation
Study Start Date : October 2009
Primary Completion Date : January 2012
Study Completion Date : January 2012

Arms and Interventions

Arm Intervention/treatment
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

Outcome Measures

Primary Outcome Measures :
  1. Change in Prolactin Levels for Individuals Treated With Adjunctive Amantadine Versus Placebo. [ Time Frame: week 4 and week 8 ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00975611

United States, Massachusetts
Freedom Trail Clinic
Boston, Massachusetts, United States, 02459
Sponsors and Collaborators
David C. Henderson, MD
Ortho-McNeil Janssen Scientific Affairs, LLC
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
First Posted: September 11, 2009    Key Record Dates
Results First Posted: June 10, 2013
Last Update Posted: June 10, 2013
Last Verified: January 2013

Keywords provided by David C. Henderson, MD, North Suffolk Mental Health Association:
schizoaffective disorder
paliperidone ER
risperidone Consta

Additional relevant MeSH terms:
Psychotic Disorders
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Paliperidone Palmitate
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
Sensory System Agents
Peripheral Nervous System Agents