Negative Symptoms of SchizophreniaPhase 3NSSNCT01234298
SPD489 as Adjunctive Treatment in Adults With Negative Symptoms of Schizophrenia
A Phase 3 study testing SPD489 Low-Dose and SPD489 High-Dose in people with Negative Symptoms of Schizophrenia, run by Shire.
Trial summary
To assess the safety and efficacy of SPD489 low-dose and high-dose treatment groups to placebo when given as adjunctive therapy to antipsychotic medication in clinically stable adults with persistent predominant negative symptoms of schizophrenia. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Negative Symptoms of Schizophrenia
- What is being tested?
- SPD489 Low-Dose and SPD489 High-Dose
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 27 Jan 2012to 24 Feb 2014
- 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 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Subject has diagnosis of schizophrenia for at least 2 years
- Subject has persistent predominant negative symptoms
- Subject has 2 or more persistent predominant negative symptoms (affective flattening, alogia, avolition apathy, and anhedonia-asociality) determined to have been present for at least 6 months
- Subject is maintained on antipsychotic monotherapy or polytherapy with no more than 2 antipsychotic medications
- Subject has been clinically stable and is in the non-acute phase of illness
Who cannot join
- Subject has clinically notable positive symptoms
- Subject is considered to be treatment refractory
- Subject has current history of substance abuse/dependance
- Subject is considered a suicide risk or risk to harm others
About this study
Official title: A Phase 3 Multicenter, Randomized, Double-blind, Parallel-group, Placebo-controlled Study to Evaluate the Efficacy, Safety, and Tolerability of Low- and High-dose Range Groups of SPD489 as Adjunctive Treatment to Established Maintenance Doses of Antipsychotic Medications on Negative Symptoms in Clinically Stable Adults Who Have Persistent Predominant Negative Symptoms of Schizophrenia
To assess the safety and efficacy of SPD489 low-dose and high-dose treatment groups to placebo when given as adjunctive therapy to antipsychotic medication in clinically stable adults with persistent predominant negative symptoms of schizophrenia.
- Conditions
- Negative Symptoms of Schizophrenia
- Being tested
- SPD489 Low-Dose, SPD489 High-Dose, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SPD489 Low-DoseDrug
Also called Vyvanse, Lisdexamfetamine dimesylate, LDX
SPD489 20, 30, or 40 mg capsules taken once-daily for up to 26 weeks
SPD489 High-DoseDrug
Also called Vyvanse, Lisdexamfetamine dimesylate, LDX
SPD489 50, 60, or 70 mg capsules taken once-daily for up to 26 weeks
PlaceboDrug
Placebo capsule taken once-daily for up to 26 weeks
| Study group | Role | What they receive |
|---|---|---|
| SPD489 Low-Dose | Experimental | Not described Receives: Drug: SPD489 Low-Dose |
| SPD489 High-Dose | Experimental | Not described Receives: Drug: SPD489 High-Dose |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Negative Symptom Assessment (NSA-16) total score
Measured: up to 26 weeks
Secondary outcomes (1)
Positive and Negative Syndrome Scale (PANSS)
Measured: up to 26 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2010 (estimated)
- Study start27 Jan 2012 (estimated)
- Primary completion24 Feb 2014 (estimated)
- Study completion24 Feb 2014 (estimated)
Why it stopped: Study was discontinued due to non-safety related business prioritization decisions
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Negative Symptoms of 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shire
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Study Director, Study director, Takeda
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01234298
- Sponsor's protocol ID
- SPD489-320
- Acronym
- NSS
- Status last verified
- May 2021
- First submitted
- 29 Oct 2010
- Last updated
- 3 Jun 2021
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 3 Multicenter, Randomized, Double-blind, Parallel-group, Placebo-controlled Study to Evaluate the Efficacy, Safety, and Tolerability of Low- and High-dose Range Groups of SPD489 as Adjunctive Treatment to Established Maintenance Doses of Antipsychotic Medications on Negative Symptoms in Clinically Stable Adults Who Have Persistent Predominant Negative Symptoms of Schizophrenia
- ClinicalTrials.gov ID
- NCT01234298
- Acronym / sponsor ID
- NSS / SPD489-320
- Conditions
- Negative Symptoms of Schizophrenia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Study was discontinued due to non-safety related business prioritization decisions
- Enrolment
- 0 participants (actual)
- Lead sponsor
- ShireIndustry (pharma, biotech, devices)
- Study start
- 27 Jan 2012 (estimated)
- Primary completion
- 24 Feb 2014 (estimated)
- Study completion
- 24 Feb 2014 (estimated)
- First posted
- 4 Nov 2010 (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.
To assess the safety and efficacy of SPD489 low-dose and high-dose treatment groups to placebo when given as adjunctive therapy to antipsychotic medication in clinically stable adults with persistent predominant negative symptoms of schizophrenia.
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 |
|---|---|---|
| SPD489 Low-Dose | Experimental | Drug: SPD489 Low-Dose |
| SPD489 High-Dose | Experimental | Drug: SPD489 High-Dose |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Subject has diagnosis of schizophrenia for at least 2 years
- Subject has persistent predominant negative symptoms
- Subject has 2 or more persistent predominant negative symptoms (affective flattening, alogia, avolition apathy, and anhedonia-asociality) determined to have been present for at least 6 months
- Subject is maintained on antipsychotic monotherapy or polytherapy with no more than 2 antipsychotic medications
- Subject has been clinically stable and is in the non-acute phase of illness
Key exclusion criteria (4 listed)
- Subject has clinically notable positive symptoms
- Subject is considered to be treatment refractory
- Subject has current history of substance abuse/dependance
- Subject is considered a suicide risk or risk to harm others
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 |
|---|---|---|
| SPD489 Low-DoseAlso: Vyvanse, Lisdexamfetamine dimesylate, LDXSPD489 20, 30, or 40 mg capsules taken once-daily for up to 26 weeks | Drug | SPD489 Low-Dose |
| SPD489 High-DoseAlso: Vyvanse, Lisdexamfetamine dimesylate, LDXSPD489 50, 60, or 70 mg capsules taken once-daily for up to 26 weeks | Drug | SPD489 High-Dose |
| PlaceboPlacebo capsule taken once-daily for up to 26 weeks | Drug | Placebo |
Primary outcome
Negative Symptom Assessment (NSA-16) total score
Time frame: up to 26 weeks
1 secondary outcome
Positive and Negative Syndrome Scale (PANSS)
Time frame: up to 26 weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2021.
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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.
Study Director study director
Takeda
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing SPD489 Low-Dose and SPD489 High-Dose in people with Negative Symptoms of Schizophrenia, run by Shire.
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 5 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: withdrawn, as of the sponsor's last update on 3 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
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?
The study was withdrawn before enrolling participants, so there are no results.
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?
Negative Symptom Assessment (NSA-16) total score (time frame: up to 26 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 3 Jun 2021.