Schizophrenia and Predominant Negative SymptomsPhase 2NCT00922272
Efficacy, Safety, and Tolerability of SPD489 in Adults With Schizophrenia and Predominant Negative Symptoms
A Phase 2 study testing SPD489 (lisdexamfetamine dimesylate) in people with Schizophrenia and Predominant Negative Symptoms, run by Shire at 27 sites in United States.
Trial summary
To explore the efficacy of SPD489, as adjunctive therapy to a stable dose of atypical antipsychotic medication, on negative symptoms in adult subjects with clinically stable schizophrenia and predominant negative symptoms, as measured by the Scale for the Assessment of Negative Symptoms (SANS). Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Schizophrenia and Predominant Negative Symptoms
- What is being tested?
- SPD489 (lisdexamfetamine dimesylate)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 92 participants
- Where
- 27 sitesUnited States
- Study dates
- 14 Sep 2009to 20 Jan 2011
- Phase
- Phase 2
- 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 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Adults aged 18-55
- Clinically stable Schizophrenia and predominant negative symptoms
- Taking a stable dose of antipsychotic medication
Who cannot join
- Clinically notable positive symptoms defined by PANSS
Trial locations and contacts
27 sites in 1 country.
27 sites in 1 country
United States27 sites
South Coast Clinical Trials
Anaheim, California, 92804
Omega Clinical Trials
Anaheim, California, 92805
Comprehensive NeuroScience
Atlanta, Georgia, 30328
Community Clinical Research, Inc.
Austin, Texas, 78756
Uptown Research Institute
Chicago, Illinois, 60640
University of Cincinnati
Cincinnati, Ohio, 45219
Clinical Innovations
Costa Mesa, California, 92626
Advanced Bio-Behavioral Sciences
Elmsford, New York, 10523
Collaborative Neuroscience Network, Inc.
Garden Grove, California, 92845
Comprehensive Neuroscience, Inc.
Hollis, New York, 11423
University Hills Clinical Research
Irving, Texas, 75062
Accurate Clinical Trials
Kissimmee, Florida, 34741
Behavioral Clinical Research, INC
Lauderhill, Florida, 33319
K&S Professional Research Services
Little Rock, Arkansas, 72201
Apostle Clinical Trials, Inc.
Long Beach, California, 90813
Segal Institute for Clinical Research (Miami)
North Miami, Florida, 33161
Excell Research, Inc.
Oceanside, California, 92056
Medical Research Group of Central Florida
Orange City, Florida, 32763
CRI Worldwide
Philadelphia, Pennsylvania, 19139
Southcoast Clinical Trials
San Bernardino, California, 92405
CNRI San Diego & Los Angeles
San Diego, California, 92102
Affiliated Research Institute
San Diego, California, 92108
Artemis Institute for Clinical Research
San Diego, California, 92123
Neuropsychiatric Research Center of Orange County
Santa Ana, California, 92701
J. Gary Booker, MD, APMC
Shreveport, Louisiana, 71104
Stedman Clinical Trials
Tampa, Florida, 33613
CRI Worldwide, LLC.
Willingboro, New Jersey, 08046
About this study
Official title: A Phase 2, Multicenter Study With Open-label & Randomized Double-blind Placebo-controlled Withdrawal Phases to Evaluate the Efficacy, Safety, & Tolerability of SPD489 in Adults With Schizophrenia & Predominant Negative Symptoms Who Are Clinically Stable & Taking Stable Doses of Atypical Antipsychotic Medication
To explore the efficacy of SPD489, as adjunctive therapy to a stable dose of atypical antipsychotic medication, on negative symptoms in adult subjects with clinically stable schizophrenia and predominant negative symptoms, as measured by the Scale for the Assessment of Negative Symptoms (SANS).
- Being tested
- SPD489 (lisdexamfetamine dimesylate), Placebo matching SPD489 (lisdexamfetamine dimesylate)
- Keywords
- Schizophrenia
- Medical subject headings
- Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SPD489 (lisdexamfetamine dimesylate)Drug
Also called Vyvanse
oral, 20, 30, 40, 50, 60, or 70 mg once daily
Placebo matching SPD489 (lisdexamfetamine dimesylate)Drug
oral, once daily
| Study group | Role | What they receive |
|---|---|---|
| SPD489 (Lisdexamfetamine dimesylate) | Experimental | Not described Receives: Drug: SPD489 (lisdexamfetamine dimesylate) |
| Placebo | Placebo comparator | Placebo Receives: Drug: Placebo matching SPD489 (lisdexamfetamine dimesylate) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Open-label Baseline in Modified Scale for the Assessment of Negative Symptoms (SANS-18) Total Score at Week 10 Open-label Phase, Last Observation Carried Forward (LOCF)
The SANS was modified by eliminating the global and attention items; the score of the remaining non-global items is referred to as the SANS-18 total score. Each of the 18-items is scored on a scale from 0 (not at all) to 5 (severe) with a total scoring range of 0 to 90. Higher scores indicate more impairment.
Measured: Open-label Baseline and Week 10 Open-label Phase
Change From Double-blind Randomization Baseline in SANS-18 Total Score at Week 4 Double-blind Phase, Termination Observation Carried Forward (TOCF)
The SANS was modified by eliminating the global and attention items; the score of the remaining non-global items is referred to as the SANS-18 total score. Each of the 18-items is scored on a scale from 0 (not at all) to 5 (severe) with a total scoring range of 0 to 90. Higher scores indicate more impairment.
Measured: Double-blind Randomization Baseline and Week 4 Double-blind Phase
Secondary outcomes (32)
Percent of Participants In Open-label Phase Who Were SANS-18 Responders at Week 10 Open-label Phase
Response is defined as reduction in total SANS score of greater than or equal to 20%. The SANS was modified by eliminating the global and attention items; the score of the remaining non-global items is referred to as the SANS-18 total score. Each of the 18-items is scored on a scale from 0 (not at all) to 5 (severe) with a total scoring range of 0 to 90. Higher scores indicate more impairment.
Measured: Week 10 Open-label Phase
Percent of Participants In Double-blind Phase Who Maintained SANS-18 Response at Week 4 Double-blind Phase
Response is defined as reduction in total SANS score of greater than or equal to 20%. The SANS was modified by eliminating the global and attention items; the score of the remaining non-global items is referred to as the SANS-18 total score. Each of the 18-items is scored on a scale from 0 (not at all) to 5 (severe) with a total scoring range of 0 to 90. Higher scores indicate more impairment.
Measured: Week 4 Double-blind Phase
Change From Open-label Baseline in SANS Global Scores at Week 10 Open-label Phase
The SANS assesses 5 symptom complexes to rate the negative symptoms of subjects. Each of the 18-items is scored on a scale from 0 (not at all) to 5 (severe) with a total scoring range of 0 to 90. Higher scores indicate more impairment.
Measured: Open-label Baseline and Week 10 Open-label Phase
Change From Double-blind Randomization Baseline in SANS Global Scores at Week 4 Double-blind Phase
The SANS assesses 5 symptom complexes to rate the negative symptoms of subjects. Each of the 18-items is scored on a scale from 0 (not at all) to 5 (severe) with a total scoring range of 0 to 90. Higher scores indicate more impairment.
Measured: Double-blind Randomization Baseline and Week 4 Double-blind Phase
Change From Open-label Baseline in Positive and Negative Syndrome Scale (PANSS) Scores at Week 10 Open-label Phase, LOCF
The PANSS is a validated measure that evaluates the presence, absence, and severity of 30 symptoms of schizophrenia including both positive and negative symptoms and general psychopathology. Each of the 30-items are rated on a scale of 1 (absent) to 7 (extreme) with a total scoring range of 30 to 210. Higher scores indicate more impairment.
Measured: Open-label Baseline and Week 10 Open-label Phase
Change From Double-blind Randomization Baseline in PANSS Scores at Week 4 Double-blind Phase, TOCF
The PANSS is a validated measure that evaluates the presence, absence, and severity of 30 symptoms of schizophrenia including both positive and negative symptoms and general psychopathology. Each of the 30-items are rated on a scale of 1 (absent) to 7 (extreme) with a total scoring range of 30 to 210. Higher scores indicate more impairment.
Measured: Double-blind Randomization Baseline and Week 4 Double-blind Phase
Percent of Participants With Clinical Global Impression - Severity of Illness (CGI-S) at Open-label Baseline
CGI-S assesses the severity of the subject's condition on a 7-point scale ranging from 1 (normal, not at all ill) to 7 (among the most extremely ill)
Measured: Open-label Baseline
Percent of Participants With CGI-S at Week 10 Open-label Phase
CGI-S assesses the severity of the subject's condition on a 7-point scale ranging from 1 (normal, not at all ill) to 7 (among the most extremely ill)
Measured: Week 10 Open-label Phase
Percent of Participants With CGI-S at Double-blind Randomization Baseline
CGI-S assesses the severity of the subject's condition on a 7-point scale ranging from 1 (normal, not at all ill) to 7 (among the most extremely ill)
Measured: Double-blind Randomization Baseline
Percent of Participants With CGI-S at Week 4 Double-blind Phase
CGI-S assesses the severity of the subject's condition on a 7-point scale ranging from 1 (normal, not at all ill) to 7 (among the most extremely ill)
Measured: Week 4 Double-blind Phase
Percent of Participants With Improvement on Clinical Global Impression - Change (CGI-C) at Week 10 Open-label Phase
CGI-C permits a global evaluation of the change of the subject's overall schizophrenia condition over time. It consists of a 7-point scale ranging from 1 (very much improved) to 7 (very much worse). Improvement is defined as a score of 1 (very much improved) or 2 (much improved) on the scale.
Measured: Open-label Phase Week 10
Percent of Participants With Improvement on CGI-C at Week 4 Double-blind Phase
CGI-C permits a global evaluation of the change of the subject's overall schizophrenia condition over time. It consists of a 7-point scale ranging from 1 (very much improved) to 7 (very much worse). Improvement is defined as a score of 1 (very much improved) or 2 (much improved) on the scale.
Measured: Double-blind Phase Week 4
Change From Open-label Baseline in the Brief Assessment of Cognition in Schizophrenia (BACS) Total Score at Week 10 Open-label Phase
BACS measures attention and speed of processing, and the test score is the total number correct. The measure of the test is the number of correct numerals where subjects write numerals 1-9 as matches to nonmeaningful symbols on a response sheet for 90 seconds, based upon a key provided to them.
Measured: Open-label Baseline and week 10 Open-label Phase
Change From Double-blind Randomization Baseline in BACS Total Score at Week 4 Double-blind Phase
BACS measures attention and speed of processing, and the test score is the total number correct. The measure of the test is the number of correct numerals where subjects write numerals 1-9 as matches to nonmeaningful symbols on a response sheet for 90 seconds, based upon a key provided to them.
Measured: Double-blind Randomization Baseline and Week 4
Change From Open-label Baseline in Letter-Number Span Test (LNS) Total Score at Week 10 Open-label Phase
LNS is a test of verbal working memory. Subjects are presented with a sequence of numbers and letters aurally and then asked to tell the rater the numbers first from lowest to highest followed by the letters in alphabetical sequence. The measure is the number of correct sequences.
Measured: Open-label Baseline and week 10 Open-label Phase
Change From Double-blind Randomization Baseline in LNS Total Score at Week 4 Double-blind Phase
LNS is a test of verbal working memory. Subjects are presented with a sequence of numbers and letters aurally and then asked to tell the rater the numbers first from lowest to highest followed by the letters in alphabetical sequence. The measure is the number of correct sequences.
Measured: Double-blind Randomization Baseline and Week 4
Change From Open-label Baseline in Hopkins Verbal Learning Test - Revised (HVLT-R) Total Score at Week 10 Open-label Phase
HVLT-R measures verbal learning. Test scores are the total number of words recalled correctly over 3 trials. The test consists of 12 nouns read aloud for 3 consecutive trials and each trial is followed by a recall test.
Measured: Open-label Baseline and Week 10
Change From Double-blind Randomization Baseline in HVLT-R Total Scores at Week 4 Double-blind Phase
HVLT-R measures verbal learning. Test scores are the total number of words recalled correctly over 3 trials. The test consists of 12 nouns read aloud for 3 consecutive trials and each trial is followed by a recall test.
Measured: Double-blind Randomization Baseline and week 4 Double-blind Phase
Change From Open-label Baseline in University of California Performance-Based Skills Assessment, Brief Version (UPSA-B) Scores at Week 10 Open-label Phase, LOCF
UPSA-B assesses skills in 5 areas of life functioning. It contains 2 subscales. Percentages correct on these 2 subscales are multiplied by 50. Thus, scores can range from 0 to 50 on each of these 2 subscales, and total scores can range from 0 to 100. Scores of 75 or higher are associated with independent living.
Measured: Open-label Baseline and week 10 Open-label Phase
Change From Double-blind Randomization Baseline in UPSA-B Scores at Week 4 Double-blind Phase
UPSA-B assesses skills in 5 areas of life functioning. It contains 2 subscales. Percentages correct on these 2 subscales are multiplied by 50. Thus, scores can range from 0 to 50 on each of these 2 subscales, and total scores can range from 0 to 100. Scores of 75 or higher are associated with independent living.
Measured: Double-blind Randomization Baseline and Week 4 Double-blind Phase
Change From Open-label Baseline in Behavioral Rating Inventory of Executive Function - Adult Version (BRIEF-A) T-scores at Week 10 Open-label Phase
BRIEF-A is a validated 75-item questionnaire composed of three indexes (Global Executive Composite, Behavioral Recognition Index, and Metacognition Index). Items are rated 1 (never), 2 (sometimes), and 3 (often). Raw scale scores are used to generate T-scores. A reduction in score indicates less impairment.
Measured: Open-label Baseline and Week 10 Open-label Phase
Change From Double-blind Randomization Baseline in BRIEF-A T-Scores at Week 4 Double-blind Phase
BRIEF-A is a validated 75-item questionnaire composed of three indexes (Global Executive Composite, Behavioral Recognition Index, and Metacognition Index). Items are rated 1 (never), 2 (sometimes), and 3 (often). Raw scale scores are used to generate T-scores. A reduction in score indicates less impairment.
Measured: Double-blind Randomization Baseline and Week 4 Double-blind Phase
Change From Open-label Baseline in Simpson Angus Scale (SAS) Total Score at Week 10 Open-label Phase
SAS is a 10-item scale used to evaluate the presence and severity of extrapyramidal symptoms. The items are scored on a scale from 0 to 4 with item-specific definitions given for each point. Total scores range from 0 to 40. Lower scores indicate less impairment.
Measured: Open-label Baseline and Week 10 Open-label Phase
Change From Open-label Baseline in SAS Total Score at Week 4 of Double-blind Phase
SAS is a 10-item scale used to evaluate the presence and severity of extrapyramidal symptoms. The items are scored on a scale from 0 to 4 with item-specific definitions given for each point. Total scores range from 0 to 40. Lower scores indicate less impairment.
Measured: Open-label Baseline and Week 4 Double-blind Phase
Change From Open-label Baseline in Barnes Akathisia Scale (BAS) Scores at Week 10 Open-label Phase
BAS scale has objective, subjective, and global impression components of akathisia (motor restlessness that manifests itself with an inability to sit still or remain motionless). Objective and subjective components are rated on a scale from 0 (normal/absence) to 3 (severe) and are summed yielding a total score of 0 to 9. Global impression is rated on a scale from 0 (absent) to 5 (severe) with a total score ranging from 0 to 5. Lower scores indicate reduced restlessness.
Measured: Open-label Baseline and week 10 Open-label Phase
Change From Open-label Baseline in BAS Scores at Week 4 of Double-blind Phase
BAS scale has objective, subjective, and global impression components of akathisia (motor restlessness that manifests itself with an inability to sit still or remain motionless). Objective and subjective components are rated on a scale from 0 (normal/absence) to 3 (severe) and are summed yielding a total score of 0 to 9. Global impression is rated on a scale from 0 (absent) to 5 (severe) with a total score ranging from 0 to 5. Lower scores indicate reduced restlessness.
Measured: Open-label Baseline and Week 4 Double-blind Phase
Change From Open-label Baseline in Amphetamine Cessation Symptom Assessment (ACSA) Total Score at Week 10 Open-label Phase
ACSA scale has 16 symptom items rated on a scale from 0 (not at all) to 4 (extremely) with a possible total score range of 0 to 64. Higher scores indicate greater withdrawal symptom severity.
Measured: Open-label Baseline and Week 10 Open-label Phase
Change From Double-blind Randomization Baseline in ACSA Total Score at Week 4 Double-blind Phase
ACSA scale has 16 symptom items rated on a scale from 0 (not at all) to 4 (extremely) with a possible total score range of 0 to 64. Higher scores indicate greater withdrawal symptom severity.
Measured: Double-blind Randomization Baseline and Week 4 Double-blind Phase
Change From Open-label Baseline in Pittsburgh Sleep Quality Index (PSQI) Total Global Score at Week 10 Open-label Phase
PSQI evaluates 7 areas of quality and pattern of sleep. Each area is rated on a scale from 0 (better) to 3 (worse) with a total score ranging from 0 to 21. Reduction in total scores are associated with better sleep quality.
Measured: Open-label Baseline and Week 10 Open-label Phase
Change From Open-label Baseline in PSQI Total Global Score at Week 4 of Double-blind Phase
PSQI evaluates 7 areas of quality and pattern of sleep. Each area is rated on a scale from 0 (better) to 3 (worse) with a total score ranging from 0 to 21. Reduction in total scores are associated with better sleep quality.
Measured: Open-label Baseline and Week 4 Double-blind Phase
Change From Open-label Baseline in Calgary Depression Scale for Schizophrenia (CDSS) at Week 10 Open-label Phase
CDSS is a 9-item scale to evaluate depression in subjects who have schizophrenia rated from 0 (absence of symptoms) to 3 (severe symptoms) with a total score range of 0 to 27. Lower scores indicate less depression.
Measured: Open-label Baseline and Week 10 Open-label Phase
Change From Open-label Baseline in CDSS at Week 4 of Double-blind Phase
CDSS is a 9-item scale to evaluate depression in subjects who have schizophrenia rated from 0 (absence of symptoms) to 3 (severe symptoms) with a total score range of 0 to 27. Lower scores indicate less depression.
Measured: Open-label Baseline and Week 4 of Double-blind Phase
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2009 (estimated)
- Study start14 Sep 2009
- Primary completion20 Jan 2011
- Study completion20 Jan 2011
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.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Schizophrenia and Predominant Negative SymptomsStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 92 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
- NCT00922272
- Sponsor's protocol ID
- SPD489-204
- Status last verified
- May 2021
- First submitted
- 15 Jun 2009
- Last updated
- 9 Jun 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Lasser RA, Dirks B, Nasrallah H, Kirsch C, Gao J, Pucci ML, Knesevich MA, Lindenmayer JP. Adjunctive lisdexamfetamine dimesylate therapy in adult outpatients with predominant negative symptoms of schizophrenia: open-label and randomized-withdrawal phases. Neuropsychopharmacology. 2013 Oct;38(11):2140-9. doi: 10.1038/npp.2013.111. Epub 2013 May 8.
PubMed 23756608
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2, Multicenter Study With Open-label & Randomized Double-blind Placebo-controlled Withdrawal Phases to Evaluate the Efficacy, Safety, & Tolerability of SPD489 in Adults With Schizophrenia & Predominant Negative Symptoms Who Are Clinically Stable & Taking Stable Doses of Atypical Antipsychotic Medication
- ClinicalTrials.gov ID
- NCT00922272
- Acronym / sponsor ID
- SPD489-204
- Keywords
- Schizophrenia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 92 participants (actual)
- Lead sponsor
- ShireIndustry (pharma, biotech, devices)
- Study start
- 14 Sep 2009 (actual)
- Primary completion
- 20 Jan 2011 (actual)
- Study completion
- 20 Jan 2011 (actual)
- First posted
- 17 Jun 2009 (estimated)
- Results
- Posted 20 Feb 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To explore the efficacy of SPD489, as adjunctive therapy to a stable dose of atypical antipsychotic medication, on negative symptoms in adult subjects with clinically stable schizophrenia and predominant negative symptoms, as measured by the Scale for the Assessment of Negative Symptoms (SANS).
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 |
|---|---|---|
| SPD489 (Lisdexamfetamine dimesylate) | Experimental | Drug: SPD489 (lisdexamfetamine dimesylate) |
| Placebo | Placebo comparator | Drug: Placebo matching SPD489 (lisdexamfetamine dimesylate)Placebo |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Adults aged 18-55
- Clinically stable Schizophrenia and predominant negative symptoms
- Taking a stable dose of antipsychotic medication
Key exclusion criteria (1 listed)
- Clinically notable positive symptoms defined by PANSS
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 (lisdexamfetamine dimesylate)Also: Vyvanseoral, 20, 30, 40, 50, 60, or 70 mg once daily | Drug | SPD489 (Lisdexamfetamine dimesylate) |
| Placebo matching SPD489 (lisdexamfetamine dimesylate)oral, once daily | Drug | Placebo |
Primary outcome
Change From Open-label Baseline in Modified Scale for the Assessment of Negative Symptoms (SANS-18) Total Score at Week 10 Open-label Phase, Last Observation Carried Forward (LOCF)
Time frame: Open-label Baseline and Week 10 Open-label Phase
The SANS was modified by eliminating the global and attention items; the score of the remaining non-global items is referred to as the SANS-18 total score. Each of the 18-items is scored on a scale from 0 (not at all) to 5 (severe) with a total scoring range of 0 to 90. Higher scores indicate more impairment.
Change From Double-blind Randomization Baseline in SANS-18 Total Score at Week 4 Double-blind Phase, Termination Observation Carried Forward (TOCF)
Time frame: Double-blind Randomization Baseline and Week 4 Double-blind Phase
The SANS was modified by eliminating the global and attention items; the score of the remaining non-global items is referred to as the SANS-18 total score. Each of the 18-items is scored on a scale from 0 (not at all) to 5 (severe) with a total scoring range of 0 to 90. Higher scores indicate more impairment.
32 secondary outcomes
Percent of Participants In Open-label Phase Who Were SANS-18 Responders at Week 10 Open-label Phase
Time frame: Week 10 Open-label Phase
Percent of Participants In Double-blind Phase Who Maintained SANS-18 Response at Week 4 Double-blind Phase
Time frame: Week 4 Double-blind Phase
Change From Open-label Baseline in SANS Global Scores at Week 10 Open-label Phase
Time frame: Open-label Baseline and Week 10 Open-label Phase
Change From Double-blind Randomization Baseline in SANS Global Scores at Week 4 Double-blind Phase
Time frame: Double-blind Randomization Baseline and Week 4 Double-blind Phase
Change From Open-label Baseline in Positive and Negative Syndrome Scale (PANSS) Scores at Week 10 Open-label Phase, LOCF
Time frame: Open-label Baseline and Week 10 Open-label Phase
Change From Double-blind Randomization Baseline in PANSS Scores at Week 4 Double-blind Phase, TOCF
Time frame: Double-blind Randomization Baseline and Week 4 Double-blind Phase
Percent of Participants With Clinical Global Impression - Severity of Illness (CGI-S) at Open-label Baseline
Time frame: Open-label Baseline
Percent of Participants With CGI-S at Week 10 Open-label Phase
Time frame: Week 10 Open-label Phase
Percent of Participants With CGI-S at Double-blind Randomization Baseline
Time frame: Double-blind Randomization Baseline
Percent of Participants With CGI-S at Week 4 Double-blind Phase
Time frame: Week 4 Double-blind Phase
Percent of Participants With Improvement on Clinical Global Impression - Change (CGI-C) at Week 10 Open-label Phase
Time frame: Open-label Phase Week 10
Percent of Participants With Improvement on CGI-C at Week 4 Double-blind Phase
Time frame: Double-blind Phase Week 4
Change From Open-label Baseline in the Brief Assessment of Cognition in Schizophrenia (BACS) Total Score at Week 10 Open-label Phase
Time frame: Open-label Baseline and week 10 Open-label Phase
Change From Double-blind Randomization Baseline in BACS Total Score at Week 4 Double-blind Phase
Time frame: Double-blind Randomization Baseline and Week 4
Change From Open-label Baseline in Letter-Number Span Test (LNS) Total Score at Week 10 Open-label Phase
Time frame: Open-label Baseline and week 10 Open-label Phase
Change From Double-blind Randomization Baseline in LNS Total Score at Week 4 Double-blind Phase
Time frame: Double-blind Randomization Baseline and Week 4
Change From Open-label Baseline in Hopkins Verbal Learning Test - Revised (HVLT-R) Total Score at Week 10 Open-label Phase
Time frame: Open-label Baseline and Week 10
Change From Double-blind Randomization Baseline in HVLT-R Total Scores at Week 4 Double-blind Phase
Time frame: Double-blind Randomization Baseline and week 4 Double-blind Phase
Change From Open-label Baseline in University of California Performance-Based Skills Assessment, Brief Version (UPSA-B) Scores at Week 10 Open-label Phase, LOCF
Time frame: Open-label Baseline and week 10 Open-label Phase
Change From Double-blind Randomization Baseline in UPSA-B Scores at Week 4 Double-blind Phase
Time frame: Double-blind Randomization Baseline and Week 4 Double-blind Phase
Change From Open-label Baseline in Behavioral Rating Inventory of Executive Function - Adult Version (BRIEF-A) T-scores at Week 10 Open-label Phase
Time frame: Open-label Baseline and Week 10 Open-label Phase
Change From Double-blind Randomization Baseline in BRIEF-A T-Scores at Week 4 Double-blind Phase
Time frame: Double-blind Randomization Baseline and Week 4 Double-blind Phase
Change From Open-label Baseline in Simpson Angus Scale (SAS) Total Score at Week 10 Open-label Phase
Time frame: Open-label Baseline and Week 10 Open-label Phase
Change From Open-label Baseline in SAS Total Score at Week 4 of Double-blind Phase
Time frame: Open-label Baseline and Week 4 Double-blind Phase
Change From Open-label Baseline in Barnes Akathisia Scale (BAS) Scores at Week 10 Open-label Phase
Time frame: Open-label Baseline and week 10 Open-label Phase
Change From Open-label Baseline in BAS Scores at Week 4 of Double-blind Phase
Time frame: Open-label Baseline and Week 4 Double-blind Phase
Change From Open-label Baseline in Amphetamine Cessation Symptom Assessment (ACSA) Total Score at Week 10 Open-label Phase
Time frame: Open-label Baseline and Week 10 Open-label Phase
Change From Double-blind Randomization Baseline in ACSA Total Score at Week 4 Double-blind Phase
Time frame: Double-blind Randomization Baseline and Week 4 Double-blind Phase
Change From Open-label Baseline in Pittsburgh Sleep Quality Index (PSQI) Total Global Score at Week 10 Open-label Phase
Time frame: Open-label Baseline and Week 10 Open-label Phase
Change From Open-label Baseline in PSQI Total Global Score at Week 4 of Double-blind Phase
Time frame: Open-label Baseline and Week 4 Double-blind Phase
Change From Open-label Baseline in Calgary Depression Scale for Schizophrenia (CDSS) at Week 10 Open-label Phase
Time frame: Open-label Baseline and Week 10 Open-label Phase
Change From Open-label Baseline in CDSS at Week 4 of Double-blind Phase
Time frame: Open-label Baseline and Week 4 of Double-blind Phase
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 23756608Lasser RA, Dirks B, Nasrallah H, Kirsch C, Gao J, Pucci ML, Knesevich MA, Lindenmayer JP. Adjunctive lisdexamfetamine dimesylate therapy in adult outpatients with predominant negative symptoms of schizophrenia: open-label and randomized-withdrawal phases. Neuropsychopharmacology. 2013 Oct;38(11):2140-9. doi: 10.1038/npp.2013.111. Epub 2013 May 8.
- FDA Recall InformationLink provided by the sponsor.
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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
27 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing SPD489 (lisdexamfetamine dimesylate) in people with Schizophrenia and Predominant Negative Symptoms, run by Shire at 27 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 3 inclusion and 1 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: finished, as of the sponsor's last update on 9 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 27 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 20 Feb 2012). 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 Open-label Baseline in Modified Scale for the Assessment of Negative Symptoms (SANS-18) Total Score at Week 10 Open-label Phase, Last Observation Carried Forward (LOCF) (time frame: Open-label Baseline and Week 10 Open-label Phase). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00922272, which also lists 1 linked publication.
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 9 Jun 2021.