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The sponsor withdrew support due to slow accrual of eligible subjects.
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| Name | Class |
|---|---|
| Ortho-McNeil Janssen Scientific Affairs, LLC | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Amantadine 100mg BID | Active Comparator | Subjects take amantadine 100mg tablets twice per day (BID) |
|
| Amantadine, 200mg BID | Active Comparator | Subjects take amantadine 200mg tablets twice per day (BID) |
|
| Amantadine, placebo BID | Placebo Comparator | Subjects take placebo tablets twice per day (BID) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Amantadine Hydrochloride, USP | Drug | amantadine tablets 100 mg. BID for 4 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Prolactin Levels for Individuals Treated With Adjunctive Amantadine Versus Placebo. | week 4 and week 8 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| David C. Henderson, M.D. | North Sufflok Mental Health Association, Freedom Trail Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Freedom Trail Clinic | Boston | Massachusetts | 02459 | United States |
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.
Subjects were recruited from the Freedom Trail Clinic, MGH Schizophrenia Program
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 (N=6), or completed (N=5), to merit statistical analysis between study arms. Therefore, only the baseline characteristics of all consented/screened subjects (N=22) were published and are reported here. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Amantadine Hydrochloride, USP | Drug | amantadine 200 mg. tablets BID for 4 weeks |
|
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| Placebo | Drug | tablets BID, for 4 weeks |
|
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| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||||||
| Age Continuous | Mean | Standard Deviation | years |
| |||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||||
| Region of Enrollment | Number | participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in Prolactin Levels for Individuals Treated With Adjunctive Amantadine Versus Placebo. | 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. | Posted | week 4 and week 8 |
|
|
entire study
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. | 0 | 6 | 0 | 6 |
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Too few subjects met study's eligibility criteria to run statistical analyses on primary outcomes. The baseline demographic data are reported here. Future research is needed to understand the prevalence of elevated prolactin in schizophrenia.
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. David Henderson | Massachusetts General Hospital Schizophrenia Research Program | (617) 912-7800 | dchenderson@partners.org |
| ID | Term |
|---|---|
| D012559 | Schizophrenia |
| D011618 | Psychotic Disorders |
| D006966 | Hyperprolactinemia |
| ID | Term |
|---|---|
| D019967 | Schizophrenia Spectrum and Other Psychotic Disorders |
| D001523 | Mental Disorders |
| D006964 | Hyperpituitarism |
| D010900 | Pituitary Diseases |
| D007027 | Hypothalamic Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| D000547 | Amantadine |
| ID | Term |
|---|---|
| D000218 | Adamantane |
| D001952 | Bridged-Ring Compounds |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
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