Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT01457339 · ClinicalTrials.gov registry record · Phase 1
Assess the Safety and Pharmacokinetics of Ascending, Multiple Oral Doses of SPD489 in Adults With Schizophrenia
A Phase 1 study of Schizophrenia, sponsored by Shire.
- Completed
- Registry status
- Phase 1
- Development phase
- 31
- Enrollment target
- 2
- Study locations
NCT01457339: Completed Phase 1 study of Schizophrenia, sponsored by Shire.
NCT01457339 is a Phase 1 study of Schizophrenia that has completed, run by Shire. The registered enrollment target is 31 participants, below the 219-participant average among 315 other Schizophrenia trials with a reported enrollment target (86% lower). The trial reports 2 study locations across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01457339, a Phase 1 study of Schizophrenia, has completed, sponsored by Shire.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 31 participants
- Enrollment target
- 2
- Study locations
Study Summary
This is a multiple ascending dose study; the purpose of this study is to examine the safety, tolerability and pharmacokinetics (levels of drug in the blood) of SPD489 in Schizophrenic Patients who are currently maintained on a stable dose of an antipsychotic medication.
Primary Outcome
Blood pressure and pulse measurements were taken using an automated blood pressure monitoring device (ideally using the same device, the same arm and in the same position throughout the study). Measurements of vital signs were performed in triplicate (3 measurements) after the subject had been in a sitting position for at least 5 minutes. Each of the 3 triplicate readings were performed in succession, at least 1-2 minutes apart, with the cuff fully deflated between measurements. It was expected
Conditions Studied
Interventions
- DRUG Placebo
- DRUG SPD489 (Lisdexamfetamine dimesylate)
Study Locations (2)
California
- California Clinical Trials - Glendale
- Collaborative Neuroscience Network, Inc - Long Beach
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 31 participants |
| Start Date | 2011-10-21 |
| Est. Completion | 2012-01-20 |
| Phase | Phase 1 |
What the finished NCT01457339 record still lists
NCT01457339 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 31 participants, a relatively small participant target, below the 219-participant average among 315 other Schizophrenia trials with a reported enrollment target (86% lower).
The record links to 1 condition, with Schizophrenia appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT01457339 reports a single indexed study location in California.
Frequently Asked Questions
What is clinical trial NCT01457339 about?
NCT01457339 is a clinical study titled "Assess the Safety and Pharmacokinetics of Ascending, Multiple Oral Doses of SPD489 in Adults With Schizophrenia". This is a multiple ascending dose study; the purpose of this study is to examine the safety, tolerability and pharmacokinetics (levels of drug in the blood) of SPD489 in Schizophrenic Patients who are currently maintained on a stable dose of an antipsychotic medication.
What is the current status of trial NCT01457339?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 31 participants. The study started on 2011-10-21. Estimated completion is 2012-01-20.
What conditions does trial NCT01457339 study?
This clinical trial studies the following conditions: Schizophrenia.
What interventions are being tested in trial NCT01457339?
The interventions under investigation include: Placebo (DRUG), SPD489 (Lisdexamfetamine dimesylate) (DRUG).
Who is sponsoring clinical trial NCT01457339?
This trial is sponsored by Shire, which has 245 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01457339 being conducted?
This trial has 2 study locations across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Schizophrenia
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT01457339's enrollment target sits among peer trials
31 259th of 315 higher than 54 of 315 other Schizophrenia trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Schizophrenia trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
-
Tolerability of MDMA in Schizophrenia
RECRUITING · Phase 1
-
Imaging Synapses With [11C] UCB-J in the Human Brain
RECRUITING · Phase 1
-
A Study to Evaluate the Dose Levels, Safety, and Drug Levels of Single KarXT Intramuscular Injection in Participants With Schizophrenia
RECRUITING · Phase 1
-
Proposal To Develop A Rapid And Cost-Effective Diagnostic Test For Schizophrenia
RECRUITING · Phase 1
-
Determining Efficacy and Safety of BXCL501 in Agitation Associated With Pediatric Schizophrenia and Bipolar Disorder
RECRUITING · Phase 1
-
Genetics of Cannabis Use Disorder and Cannabinoid Response in Humans
RECRUITING · Phase 1
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT02932618 · 31 participants · Phase 3
A Study of Recombinant Von Willebrand Factor (rVWF) With or Without ADVATE in Children With Severe Von Willebrand Disease (VWD)
- NCT03482297 · 31 participants · Phase 1
Automated Abdominal Binder for Orthostatic Hypotension
- NCT04016389 · 31 participants · NA
FIGO 2018 Stage IB2 Cervical Cancer Treated With Neoadjuvant Chemotherapy Followed by Fertility Sparing Surgery
- NCT04211675 · 31 participants · Phase 1
NK Cells Infusions With Irinotecan, Temozolomide, and Dinutuximab
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI