A Phase 4 interventional study of Amantadine Hydrochloride, USP and Amantadine Hydrochloride, USP in Schizophrenia and Schizoaffective Disorder, sponsored by David C. Henderson, MD. Terminated at 1 site in United States. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2013-06-10.
Sponsored by David C. Henderson, MD · Phase 4, Interventional, and Treatment
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.
3,470 studies on the registry are indexed under Schizophrenia; 471 are open to participants now.
This study's enrollment of 6 is below the median of 70 across 2,871 interventional studies indexed under Schizophrenia.
Browse Schizophrenia studies →This is the only study on the registry with David C. Henderson, MD as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Subjects take amantadine 100mg tablets twice per day (BID)
Drug: Amantadine Hydrochloride, USP
Subjects take amantadine 200mg tablets twice per day (BID)
Drug: Amantadine Hydrochloride, USP
Subjects take placebo tablets twice per day (BID)
Drug: Placebo
amantadine tablets 100 mg. BID for 4 weeks
Also known as: Symmetrel
amantadine 200 mg. tablets BID for 4 weeks
Also known as: Symmetrel
tablets BID, for 4 weeks
Also known as: Symmetrel placebo
Change in Prolactin Levels for Individuals Treated With Adjunctive Amantadine Versus Placebo.
Time frame: week 4 and week 8
Subjects were recruited from the Freedom Trail Clinic, MGH Schizophrenia Program
| Milestone | All Consented Subjects |
|---|---|
| Started | 22 |
| Completed | 5 |
| Not completed | 17 |
| Withdrew: Screen fail | 16 |
| Withdrew: Physician decision | 1 |
No measurements were reported for this outcome.
Collected over entire study. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| All Consented Subjects | — | 0/6 (0%) | 0/6 (0%) |
| Age, Categorical(Participants) | All Consented Subjects |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 22 |
| >=65 years | 0 |
| Age Continuous(years) | All Consented Subjects |
|---|---|
| Mean | 43.14 ± 10.95 |
| Sex: Female, Male(Participants) | All Consented Subjects |
|---|---|
| Female | 7 |
| Male | 15 |
| Region of Enrollment(participants) | All Consented Subjects |
|---|---|
| United States | 22 |
This study is terminated, as verified in Jan 2013. You cannot join it, but the record below documents what was studied.
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