Study of Amantadine for Risperidone Consta or Paliperidone Treated Patients to Decrease Prolactin Elevation
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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 |
- 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 ]
- 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 ]
| 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 |
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 |
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| United States, Massachusetts | |
| Freedom Trail Clinic | |
| Boston, Massachusetts, United States, 02459 | |
| 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: | April 23, 2012 |
| 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 May 23, 2013