SchizophreniaPhase 4NCT00975611
Study of Amantadine for Risperidone Consta or Paliperidone Treated Patients to Decrease Prolactin Elevation
A Phase 4 study testing Amantadine Hydrochloride, USP in people with Schizophrenia and Schizoaffective Disorder, run by David C. Henderson, MD at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Schizophrenia, Schizoaffective Disorder
- What is being tested?
- Amantadine Hydrochloride, USP
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 6 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2009to Jan 2012
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Amantadine Addition to Paliperidone ER or Risperidone Consta Therapy for Prolactin Elevation
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.
Read the 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.
- Conditions
- Schizophrenia, Schizoaffective Disorder
- Being tested
- Amantadine Hydrochloride, USP, Placebo
- Keywords
- schizophrenia, schizoaffective disorder, paliperidone ER, risperidone Consta, prolactin, hyperprolactinemia
- Medical subject headings
- Schizophrenia, Psychotic Disorders, Hyperprolactinemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Amantadine Hydrochloride, USPDrug
Also called Symmetrel
amantadine tablets 100 mg. BID for 4 weeks
Amantadine Hydrochloride, USPDrug
Also called Symmetrel
amantadine 200 mg. tablets BID for 4 weeks
PlaceboDrug
Also called Symmetrel placebo
tablets BID, for 4 weeks
| Study group | Role | What they receive |
|---|---|---|
| Amantadine 100mg BID | Active comparator | Subjects take amantadine 100mg tablets twice per day (BID) Receives: Drug: Amantadine Hydrochloride, USP |
| Amantadine, 200mg BID | Active comparator | Subjects take amantadine 200mg tablets twice per day (BID) Receives: Drug: Amantadine Hydrochloride, USP |
| Amantadine, placebo BID | Placebo comparator | Subjects take placebo tablets twice per day (BID) Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Prolactin Levels for Individuals Treated With Adjunctive Amantadine Versus Placebo.
Measured: week 4 and week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2009 (estimated)
- Study startOct 2009
- Primary completionJan 2012
- Study completionJan 2012
Why it stopped: The sponsor withdrew support due to slow accrual of eligible subjects.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- David C. Henderson, MD
- Sponsor type
- University, hospital or other
- Collaborators
- Ortho-McNeil Janssen Scientific Affairs, LLC
- Responsible party
- Sponsor-investigator, David C. Henderson, MD, North Suffolk Mental Health Association
- Investigators
- David C. Henderson, M.D., Principal investigator, North Sufflok Mental Health Association, Freedom Trail Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00975611
- Sponsor's protocol ID
- R076477PD14002
- Status last verified
- Jan 2013
- First submitted
- 10 Sep 2009
- Last updated
- 10 Jun 2013
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Amantadine Addition to Paliperidone ER or Risperidone Consta Therapy for Prolactin Elevation
- ClinicalTrials.gov ID
- NCT00975611
- Acronym / sponsor ID
- R076477PD14002
- Conditions
- Schizophrenia, Schizoaffective Disorder
- Keywords
- schizophrenia, schizoaffective disorder, paliperidone ER, risperidone Consta, prolactin, hyperprolactinemia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The sponsor withdrew support due to slow accrual of eligible subjects.
- Enrolment
- 6 participants (actual)
- Lead sponsor
- David C. Henderson, MDUniversity, hospital or other
- Collaborators
- Ortho-McNeil Janssen Scientific Affairs, LLC
- Study start
- Oct 2009
- Primary completion
- Jan 2012 (actual)
- Study completion
- Jan 2012 (actual)
- First posted
- 11 Sep 2009 (estimated)
- Results
- Posted 10 Jun 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Amantadine 100mg BID | Active comparator | Drug: Amantadine Hydrochloride, USPSubjects take amantadine 100mg tablets twice per day (BID) |
| Amantadine, 200mg BID | Active comparator | Drug: Amantadine Hydrochloride, USPSubjects take amantadine 200mg tablets twice per day (BID) |
| Amantadine, placebo BID | Placebo comparator | Drug: PlaceboSubjects take placebo tablets twice per day (BID) |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Amantadine Hydrochloride, USPAlso: Symmetrelamantadine tablets 100 mg. BID for 4 weeks | Drug | Amantadine 100mg BID |
| Amantadine Hydrochloride, USPAlso: Symmetrelamantadine 200 mg. tablets BID for 4 weeks | Drug | Amantadine, 200mg BID |
| PlaceboAlso: Symmetrel placebotablets BID, for 4 weeks | Drug | Amantadine, placebo BID |
Primary outcome
Change in Prolactin Levels for Individuals Treated With Adjunctive Amantadine Versus Placebo.
Time frame: week 4 and week 8
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jun 2013.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David C. Henderson, M.D. principal investigator
North Sufflok Mental Health Association, Freedom Trail Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Amantadine Hydrochloride, USP in people with Schizophrenia and Schizoaffective Disorder, run by David C. Henderson, MD at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 10 Jun 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 10 Jun 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Prolactin Levels for Individuals Treated With Adjunctive Amantadine Versus Placebo. (time frame: week 4 and week 8). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jun 2013.