drugset / Trial / NCT00975611
Study of Amantadine for Risperidone Consta or Paliperidone Treated Patients to Decrease Prolactin Elevation
Phase 4
Terminated
6 enrolled
David C. Henderson, MD
Ortho-McNeil Janssen Scientific Affairs, LLC · collab
RandomizedParallel-groupQuadruple-blindTreatment
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.
Timeline
- Start
- 2009-10
- Primary completion
- 2012-01
- Completion
- 2012-01
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Amantadine | Unknown | 100 mg | — |
| Comparator | Amantadine | Unknown | 200 mg | — |