SchizophreniaPhase 3NCT01760889
SPD489 Low Dose and High Dose Ranges When Added to Stable Doses of Antipsychotic Medications in Clinically Stable Adults With Negative Symptoms of Schizophrenia
A Phase 3 study testing SPD489 low dose range (40mg, 80mg, and 100mg) and SPD489 high dose range (120mg, 140mg and 160mg) in people with Schizophrenia, run by Shire at 4 sites in United States.
Trial summary
The primary purpose of this study is to determine whether SPD489 low dose range (40, 80, or 100mg) and high dose range (120, 140, or 160mg) are effective in the treatment of Negative Symptoms. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Schizophrenia
- What is being tested?
- SPD489 low dose range (40mg, 80mg, and 100mg) and SPD489 high dose range (120mg, 140mg and 160mg)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1 participants
- Where
- 4 sitesUnited States
- Study dates
- 1 Feb 2013to 1 Apr 2013
- Phase
- Phase 3
- 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
- - 18 to 65 years of age
- Has a reliable informant (eg, family member, social worker, caseworker, or nurse that spends >4 hours/week with the subject)
- Fixed home/place of residence and can be reached by telephone
- On a stable dose of antipsychotic medications
- Able to swallow capsules
Who cannot join
- Taking lithium, carbamazepine, lamotrigine, gabapentin, cholinesterase inhibitors, modafinil, or other stimulants such as methylphenidate and other amphetamine products
- Treated with clozapine in past 30 days
- Lifetime history of stimulant, cocaine, or amphetamine abuse or dependence
- History of seizures (other than infantile febrile seizures), any tic disorder, or current diagnosis and/or a known family history of Tourette's Disorder, serious neurological disease, history of significant head trauma, dementia, cerebrovascular disease, Parkinson's disease, or intracranial lesions
- Uncontrolled hypertension
- History of thyroid disorder that has not been stabilized on thyroid medication
Show all 9Show fewer
- Glaucoma
- Pregnant or nursing
- Subject has received an investigational product or participated in a clinical study within 30 days
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Galiz Research
Miami Springs, Florida, 33166
Psychiatric Care and Research Center
O'Fallon, Missouri, 63368
CRI Lifetree
Philadelphia, Pennsylvania, 19139
St. Charles Psychiatric Associates
Saint Charles, Missouri, 63304
About this study
Official title: A Phase 3 Multicenter, Randomized, Double-blind, Parallel-group, Placebo-controlled, 26-week, Dose-optimization Study to Evaluate the Efficacy, Safety, and Tolerability of SPD489 Low Dose Range (40mg, 80mg, 100mg) and High Dose Range (120mg, 140mg, 160mg) 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
The primary purpose of this study is to determine whether SPD489 low dose range (40, 80, or 100mg) and high dose range (120, 140, or 160mg) are effective in the treatment of Negative Symptoms.
- Conditions
- Schizophrenia
- Being tested
- SPD489 low dose range (40mg, 80mg, and 100mg), SPD489 high dose range (120mg, 140mg and 160mg), Placebo
- Medical subject headings
- Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SPD489 low dose range (40mg, 80mg, and 100mg)Drug
Also called lisdexamfetamine dimesylate, LDX, Vyvanse
Capsule, dose titration,
- 40 mg capsule once-daily for 1 week; then
- 80 mg capsule once-daily for 4 weeks; then,
- 100 mg capsule once-daily (if unable to tolerate 100 mg dose between weeks 5 to 6, then dose to be decreased to 80 mg once-daily for the remaining 21 weeks;
- if able to tolerate 100 mg dose then will continue on 100 mg capsule once-daily for 21 weeks
SPD489 high dose range (120mg, 140mg and 160mg)Drug
Also called lisdexamfetamine dimesylate, LDX, Vyvanse
Capsule, dose titration,
- 40 mg capsule once-daily for 1 week; then
- 80 mg capsule once daily for 1 week; then
- 120 mg capsule once-daily for 1 week, then,
- 140 mg capsule once-daily for 2 weeks, then
- 160 mg once capsule once-daily (if unable to tolerate 160 mg dose between weeks 5 to 6, then dose to be decreased to 140 mg once-daily for the remaining 21 weeks;
- if able to tolerate 160 mg dose then will continue on 160 mg capsule once-daily for 21 weeks
PlaceboDrug
One capsule a day for 26 weeks
| Study group | Role | What they receive |
|---|---|---|
| SPD489 Low Dose Range | Experimental | Not described Receives: Drug: SPD489 low dose range (40mg, 80mg, and 100mg) |
| SPD489 High Dose Range | Experimental | Not described Receives: Drug: SPD489 high dose range (120mg, 140mg and 160mg) |
| 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.
Change From Baseline in Negative Symptom Assessment (NSA-16) Total Score at 26 Weeks
Measured: Baseline and 26 weeks
Secondary outcomes (13)
Change From Baseline in the Personal and Social Performance (PSP) Scale Score at 26 Weeks
Measured: Baseline and 26 weeks
Change From Baseline in Simpson Angus Scale (SAS) Total Score at 26 Weeks
Measured: Baseline and 26 weeks
Change From Baseline in Barnes Akathisia Scale (BAS) Total Score at 26 Weeks
Measured: Baseline and 26 weeks
Change From Baseline in the Abnormal Involuntary Movement Scale (AIMS) at 26 Weeks
Measured: Baseline and 26 weeks
Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Scores at 26 Weeks
Measured: Baseline and 26 weeks
Change From Baseline in Cognitive Test Battery (CogState Battery) Score at 26 Weeks
Measured: Baseline and 26 weeks
Change From Baseline in Social Functioning Scale (SFS) at 26 Weeks
Measured: Baseline and 26 weeks
Clinical Global Impression-Schizophrenia Severity of Illness (CGI-SCH-S) Scale
Measured: Baseline and week 26
Clinical Global Impression-Schizophrenia Degree of Change (CGI-SCH-C) Scale
Measured: Up to 26 weeks
Change From Baseline in Amphetamine Cessation Symptom Assessment (ACSA) Total Score at 26 Weeks
Measured: Baseline and 26 weeks
Change From Baseline in Clinical Evaluation of Harmful Behavior (CEHB) Scale at 26 Weeks
Measured: Baseline and 26 weeks
Columbia-Suicide Severity Rating Scale (C-SSRS)
Measured: Up to 26 weeks
Change From Baseline in Calgary Depression Scale for Schizophrenia (CDSS) at 26 Weeks
Measured: Baseline and 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 Jan 2013 (estimated)
- Study start1 Feb 2013
- Primary completion1 Apr 2013
- Study completion1 Apr 2013
Why it stopped: Study was discontinued due to non-safety related business prioritization decisions. No subjects were randomized
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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 1 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
- NCT01760889
- Sponsor's protocol ID
- SPD489-335
- Other IDs
- 2012-003919-57
- Status last verified
- May 2021
- First submitted
- 2 Jan 2013
- Last updated
- 22 Jun 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 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, 26-week, Dose-optimization Study to Evaluate the Efficacy, Safety, and Tolerability of SPD489 Low Dose Range (40mg, 80mg, 100mg) and High Dose Range (120mg, 140mg, 160mg) 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
- NCT01760889
- Acronym / sponsor ID
- SPD489-335
- Conditions
- Schizophrenia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study was discontinued due to non-safety related business prioritization decisions. No subjects were randomized
- Enrolment
- 1 participants (actual)
- Lead sponsor
- ShireIndustry (pharma, biotech, devices)
- Study start
- 1 Feb 2013 (actual)
- Primary completion
- 1 Apr 2013 (actual)
- Study completion
- 1 Apr 2013 (actual)
- First posted
- 4 Jan 2013 (estimated)
- Results
- Posted 29 May 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary purpose of this study is to determine whether SPD489 low dose range (40, 80, or 100mg) and high dose range (120, 140, or 160mg) are effective in the treatment of Negative Symptoms.
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 Range | Experimental | Drug: SPD489 low dose range (40mg, 80mg, and 100mg) |
| SPD489 High Dose Range | Experimental | Drug: SPD489 high dose range (120mg, 140mg and 160mg) |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- - 18 to 65 years of age
- Has a reliable informant (eg, family member, social worker, caseworker, or nurse that spends >4 hours/week with the subject)
- Fixed home/place of residence and can be reached by telephone
- On a stable dose of antipsychotic medications
- Able to swallow capsules
Key exclusion criteria (9 listed)
- Taking lithium, carbamazepine, lamotrigine, gabapentin, cholinesterase inhibitors, modafinil, or other stimulants such as methylphenidate and other amphetamine products
- Treated with clozapine in past 30 days
- Lifetime history of stimulant, cocaine, or amphetamine abuse or dependence
- History of seizures (other than infantile febrile seizures), any tic disorder, or current diagnosis and/or a known family history of Tourette's Disorder, serious neurological disease, history of significant head trauma, dementia, cerebrovascular disease, Parkinson's disease, or intracranial lesions
- Uncontrolled hypertension
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 dose range (40mg, 80mg, and 100mg)Also: lisdexamfetamine dimesylate, LDX, VyvanseCapsule, dose titration, * 40 mg capsule once-daily for 1 week; then * 80 mg capsule once-daily for 4 weeks; then, * 100 mg capsule once-daily (if unable to tolerate 100 mg dose between weeks 5 to 6, then dose to be decreased to 80 mg once-daily for the remaining 21 weeks; * if able to tolerate 100 mg dose then will continue on 100 mg capsule once-daily for 21 weeks | Drug | SPD489 Low Dose Range |
| SPD489 high dose range (120mg, 140mg and 160mg)Also: lisdexamfetamine dimesylate, LDX, VyvanseCapsule, dose titration, * 40 mg capsule once-daily for 1 week; then * 80 mg capsule once daily for 1 week; then * 120 mg capsule once-daily for 1 week, then, * 140 mg capsule once-daily for 2 weeks, then * 160 mg once capsule once-daily (if unable to tolerate 160 mg dose between weeks 5 to 6, then dose to be decreased to 140 mg once-daily for the remaining 21 weeks; * if able to tolerate 160 mg dose then will continue on 160 mg capsule once-daily for 21 weeks | Drug | SPD489 High Dose Range |
| PlaceboOne capsule a day for 26 weeks | Drug | Placebo |
Primary outcome
Change From Baseline in Negative Symptom Assessment (NSA-16) Total Score at 26 Weeks
Time frame: Baseline and 26 weeks
13 secondary outcomes
Change From Baseline in the Personal and Social Performance (PSP) Scale Score at 26 Weeks
Time frame: Baseline and 26 weeks
Change From Baseline in Simpson Angus Scale (SAS) Total Score at 26 Weeks
Time frame: Baseline and 26 weeks
Change From Baseline in Barnes Akathisia Scale (BAS) Total Score at 26 Weeks
Time frame: Baseline and 26 weeks
Change From Baseline in the Abnormal Involuntary Movement Scale (AIMS) at 26 Weeks
Time frame: Baseline and 26 weeks
Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Scores at 26 Weeks
Time frame: Baseline and 26 weeks
Change From Baseline in Cognitive Test Battery (CogState Battery) Score at 26 Weeks
Time frame: Baseline and 26 weeks
Change From Baseline in Social Functioning Scale (SFS) at 26 Weeks
Time frame: Baseline and 26 weeks
Clinical Global Impression-Schizophrenia Severity of Illness (CGI-SCH-S) Scale
Time frame: Baseline and week 26
Clinical Global Impression-Schizophrenia Degree of Change (CGI-SCH-C) Scale
Time frame: Up to 26 weeks
Change From Baseline in Amphetamine Cessation Symptom Assessment (ACSA) Total Score at 26 Weeks
Time frame: Baseline and 26 weeks
Change From Baseline in Clinical Evaluation of Harmful Behavior (CEHB) Scale at 26 Weeks
Time frame: Baseline and 26 weeks
Columbia-Suicide Severity Rating Scale (C-SSRS)
Time frame: Up to 26 weeks
Change From Baseline in Calgary Depression Scale for Schizophrenia (CDSS) at 26 Weeks
Time frame: Baseline and 26 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2021.
- 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.
Study Director study director
Takeda
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing SPD489 low dose range (40mg, 80mg, and 100mg) and SPD489 high dose range (120mg, 140mg and 160mg) in people with Schizophrenia, run by Shire at 4 sites 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 5 inclusion and 9 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 22 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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 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?
Yes. Results are posted in the registry (first posted 29 May 2014). 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 From Baseline in Negative Symptom Assessment (NSA-16) Total Score at 26 Weeks (time frame: Baseline and 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 22 Jun 2021.