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

Stopped early · Phase 4 · Has a placebo group

Conditions studied: Schizophrenia, Schizoaffective Disorder

In brief

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.

Key facts

Study ID

NCT00975611

Run by

David C. Henderson, MD

People needed

6

Starts

2009-10-01

Expected to finish

2012-01-01

Last updated by the study team

2013-06-10

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Freedom Trail Clinic — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

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