Conditions: Schizophrenia Schizoaffective Disorder
Keywords: schizophrenia schizoaffective disorder paliperidone ER risperidone Consta prolactin hyperprolactinemia
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 6
Healthy volunteers: no

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.

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.

Arms:
arm 1: Subjects take amantadine 100mg tablets twice per day (BID) arm 2: Subjects take amantadine 200mg tablets twice per day (BID) arm 3: Subjects take placebo tablets twice per day (BID)

Interventions: intervention 1: Amantadine Hydrochloride, USP intervention 2: Amantadine Hydrochloride, USP intervention 3: Placebo
Intervention descriptions: intervention 1: amantadine tablets 100 mg. BID for 4 weeks intervention 2: amantadine 200 mg. tablets BID for 4 weeks intervention 3: tablets BID, for 4 weeks

Protocol document: