Clinical trial NCT00975611: Study of Amantadine for Risperidone Consta or Paliperidone Treated Patients to Decrease Prolactin Elevation
Official title: Amantadine Addition to Paliperidone ER or Risperidone Consta Therapy for Prolactin Elevation
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Schizophrenia
Schizoaffective Disorder
Keywords: schizophrenia
schizoaffective disorder
paliperidone ER
risperidone Consta
prolactin
hyperprolactinemia
Lead sponsor: North Suffolk Mental Health Association
Sponsor class: OTHER
Collaborators: name: Ortho-McNeil Janssen Scientific Affairs, LLC
First posted: 2009-09-11
Enrollment: 6
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: Change in Prolactin Levels for Individuals Treated With Adjunctive Amantadine Versus Placebo.
timeFrame: week 4 and week 8
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Freedom Trail Clinic
state: Massachusetts
Study officials:
affiliation: North Sufflok Mental Health Association, Freedom Trail Clinic
name: David C. Henderson, M.D.
role: PRINCIPAL_INVESTIGATOR
References: