SchizophreniaPhase 3NCT00999505
Amantadine as Adjunctive Therapy to Antipsychotics in Schizophrenia
A Phase 3 study testing Amantadine in people with Schizophrenia, run by Hospital de Clinicas de Porto Alegre at 1 site in Brazil.
Trial summary
Amantadine as add-on therapy to antipsychotics may improve schizophrenia positive, negative and cognitive symptoms. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Schizophrenia
- What is being tested?
- Amantadine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteBrazil
- Study dates
- May 2010to Sep 2011
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Under antipsychotics with residual symptoms
Who cannot join
- Pregnancy
- Lactation
Trial locations and contacts
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
Hospital de Clinicas de Porto Alegre
Porto Alegre, Rio Grande do Sul, 90035-903
David Lucena, MD
About this study
Official title: A Double-blind, Randomized, Placebo-controlled Trial With Amantadine as Adjunctive Therapy to Antipsychotics in Schizophrenia
Amantadine as add-on therapy to antipsychotics may improve schizophrenia positive, negative and cognitive symptoms.
- Conditions
- Schizophrenia
- Being tested
- Amantadine, Placebo
- Keywords
- Schizophrenia, Amantadine, Residual symptoms
- Medical subject headings
- Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AmantadineDrug
Also called Mantidan TM
Amantadine 200mg twice a day over 12 weeks
PlaceboDrug
Placebo capsules twice a day over 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| Amantadine | Active comparator | Amantadine 200mg twice a day Receives: Drug: Amantadine |
| Placebo | Placebo comparator | Placebo capsules twice a day Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Scores in Brief Psychiatric Rating Scale
Measured: Baseline, 4 weeks, 8 weeks, 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2009 (estimated)
- Study startMay 2010
- Primary completionSep 2011 (estimated)
- Study completionSep 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- More trials run by Hospital de Clinicas de Porto AlegreThe sponsor's other registered studies.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital de Clinicas de Porto Alegre
- Sponsor type
- University, hospital or other
- Investigators
- Clarissa S Gama, MD, PhD, Principal investigator, Hospital de Clinicas de Porto Alegre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00999505
- Sponsor's protocol ID
- 09-303
- Other IDs
- 09-303
- Status last verified
- Feb 2011
- First submitted
- 20 Oct 2009
- Last updated
- 16 Feb 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Feb 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-blind, Randomized, Placebo-controlled Trial With Amantadine as Adjunctive Therapy to Antipsychotics in Schizophrenia
- ClinicalTrials.gov ID
- NCT00999505
- Acronym / sponsor ID
- 09-303
- Conditions
- Schizophrenia
- Keywords
- Schizophrenia, Amantadine, Residual symptoms
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Hospital de Clinicas de Porto AlegreUniversity, hospital or other
- Study start
- May 2010
- Primary completion
- Sep 2011 (estimated)
- Study completion
- Sep 2011 (estimated)
- First posted
- 21 Oct 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Amantadine as add-on therapy to antipsychotics may improve schizophrenia positive, negative and cognitive symptoms.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Amantadine | Active comparator | Drug: AmantadineAmantadine 200mg twice a day |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo capsules twice a day |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Under antipsychotics with residual symptoms
Key exclusion criteria (2 listed)
- Pregnancy
- Lactation
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 |
|---|---|---|
| AmantadineAlso: Mantidan TMAmantadine 200mg twice a day over 12 weeks | Drug | Amantadine |
| PlaceboPlacebo capsules twice a day over 12 weeks | Drug | Placebo |
Primary outcome
Scores in Brief Psychiatric Rating Scale
Time frame: Baseline, 4 weeks, 8 weeks, 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Feb 2011.
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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.
Clarissa S Gama, MD, PhD principal investigator
Hospital de Clinicas de Porto Alegre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Amantadine in people with Schizophrenia, run by Hospital de Clinicas de Porto Alegre at 1 site in Brazil.
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 1 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 16 Feb 2011. 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 Brazil. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Clarissa S Gama, MD, PhD (55-51-33598745, csgama@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Scores in Brief Psychiatric Rating Scale (time frame: Baseline, 4 weeks, 8 weeks, 12 weeks). 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 16 Feb 2011.