Study of Amantadine for Risperidone Consta or Paliperidone Treated Patients to Decrease Prolactin Elevation
| Status: | Archived |
|---|---|
| Conditions: | Schizophrenia, Psychiatric |
| Therapuetic Areas: | Psychiatry / Psychology |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 7/1/2011 |
| Start Date: | October 2009 |
| End Date: | September 2011 |
Amantadine Addition to Paliperidone ER or Risperidone Consta Therapy for Prolactin Elevation
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.
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.
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