Study of Amantadine for Risperidone Consta or Paliperidone Treated Patients to Decrease Prolactin Elevation
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
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
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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 |
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 |

Arm | Intervention/treatment |
---|---|
Active Comparator: Amantadine 100mg BID
Subjects take amantadine 100mg tablets twice per day (BID)
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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)
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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)
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Drug: Placebo
tablets BID, for 4 weeks
Other Name: Symmetrel placebo |
- Change in Prolactin Levels for Individuals Treated With Adjunctive Amantadine Versus Placebo. [ Time Frame: week 4 and week 8 ]

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Ages Eligible for Study: | 18 Years to 65 Years (Adult, Older 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

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 |
Principal Investigator: | David C. Henderson, M.D. | North Sufflok Mental Health Association, Freedom Trail Clinic |
Responsible Party: | David C. Henderson, MD, Associate Professor, North Suffolk Mental Health Association |
ClinicalTrials.gov Identifier: | NCT00975611 |
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 |
schizophrenia schizoaffective disorder paliperidone ER |
risperidone Consta prolactin hyperprolactinemia |
Schizophrenia Psychotic Disorders Schizophrenia Spectrum and Other Psychotic Disorders Mental Disorders Amantadine Antiparkinson Agents Anti-Dyskinesia Agents 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 |