Schizoaffective Disorder, Schizophrenia
Conditions
Keywords
schizophrenia, schizoaffective disorder, paliperidone ER, risperidone Consta, prolactin, hyperprolactinemia
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.
Interventions
DRUGAmantadine Hydrochloride, USP
amantadine tablets 100 mg. BID for 4 weeks
DRUGPlacebo
tablets BID, for 4 weeks
Sponsors
Ortho-McNeil Janssen Scientific Affairs, LLC
David C. Henderson, MD
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in Prolactin Levels for Individuals Treated With Adjunctive Amantadine Versus Placebo. | week 4 and week 8 |
Countries
United States
Participant flow
Recruitment details
Subjects were recruited from the Freedom Trail Clinic, MGH Schizophrenia Program
Pre-assignment details
Of the 22 consented subjects, 15 screen-failed because prolactin levels did not meet eligibility criteria, and 1 screen failed due to a positive drug screen.
Participants by arm
| Arm | Count |
|---|---|
| All Consented Subjects Of the 22 consented subjects, 15 screen-failed because prolactin levels did not meet eligibility criteria and 1 screen-failed due to a positive drug screen. Because of this unanticipated high screen-failure rate, the study was terminated. Not enough subjects were randomized or completed to merit statistical analysis between study arms. Therefore, only the baseline characteristics of all 22 consented/screened subjects were published and are reported here. | 22 |
| Total | 22 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Physician Decision | 1 |
| Overall Study | Screen Fail | 16 |
Baseline characteristics
| Characteristic | All Consented Subjects |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 22 Participants |
| Age Continuous | 43.14 years STANDARD_DEVIATION 10.95 |
| Region of Enrollment United States | 22 participants |
| Sex: Female, Male Female | 7 Participants |
| Sex: Female, Male Male | 15 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 6 |
| serious Total, serious adverse events | 0 / 6 |
Outcome results
Primary
Change in Prolactin Levels for Individuals Treated With Adjunctive Amantadine Versus Placebo.
Time frame: week 4 and week 8
Population: Of the 22 consented subjects, 15 screen-failed because prolactin levels did not meet eligibility criteria and 1 screen-failed due to a positive drug screen. Because of this unanticipated high screen-failure rate, the study was terminated. Only baseline characteristics of all 22 consented/screened subjects were published and are reported here.