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

• Status: Terminated
• Trial end date: 2012-01-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: David C. Henderson, MD
• Collaborator: Ortho-McNeil Janssen Scientific Affairs, LLC
• Treatments: Amantadine; Paliperidone Palmitate; Risperidone

Criteria

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