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

• ClinicalTrials.gov Identifier: NCT00975611
• Recruitment Status: Terminated
• First Posted: September 11, 2009
• Results First Posted: June 10, 2013
• Last Update Posted: June 10, 2013
• 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

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
• Actual Primary Completion Date: January 2012
• Actual 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

• Ages Eligible for Study: 18 Years to 65 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• 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

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
• First Posted: September 11, 2009
• 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:

schizophrenia; schizoaffective disorder; paliperidone ER; risperidone Consta; prolactin; hyperprolactinemia

Additional relevant MeSH terms:

Schizophrenia; Psychotic Disorders; Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders; Amantadine; Risperidone; 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; Analgesics; Sensory System Agents; Peripheral Nervous System Agents