NCT00403546|CompletedPhase 3ResultsDMC
High-Dose Oral Ziprasidone Versus Conventional Dosing in Participants With Residual Schizophrenia Symptoms
HDZ
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Sponsor study identifier
interventional
131
1 country
9
Study Start
January 2006
Actual (reported)Primary Completion
May 2011
Actual (reported)Study Completion
May 2011
Actual (reported)The primary aims of this study are to assess tolerability of ziprasidone dose escalation to 320 milligrams per day (mg/d) compared to continued standard treatment (placebo) as measured by the Side Effect Checklist, Simpson Angus Scale for Extrapyramidal Symptoms (SAS), Barnes Akathisia Scale (BAS), serum prolactin concentrations, vital signs, electrocardiogram (EKG) and completion rates and to assess whether ziprasidone dose escalation improves overall psychopathology compared to continued standard treatment as measured by the change from baseline in the Positive and Negative Syndrome Scale (PANSS) total score and response rates as defined by a 20% or greater reduction in PANSS total score. The secondary aims of this study are to assess whether ziprasidone dose escalation improves psychotic symptoms compared to continued standard treatment as measured by the Positive Symptom Subscale of the PANSS, to assess whether ziprasidone dose escalation improves negative symptoms compared to standard treatment as measured by the Negative Symptom Subscale of the PANSS, to assess whether ziprasidone dose escalation improves depressive symptoms compared to continued standard treatment as measured by the Calgary Depression Rating Scale (CDRS), and to assess whether ziprasidone dose escalation improves overall functioning with the Clinical Global Impression - Severity (CGI-S), Clinical Global Impression - Improvement (CGI-I), Global Assessment of Functioning (GAF) and the Schizophrenia Cognition Rating Scale (SCoRS).
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
May 2011
Actual (reported)Click on a node to explore related trials.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
January 2006
Actual (reported)November 21, 2006
Actual (reported)November 23, 2006
Actual (reported)May 2011
Actual (reported)May 2011
Actual (reported)June 6, 2017
Actual (reported)Number of Events Recorded Based on Ziprasidone Side Effects Checklist During Randomized Trial
Side effects were tracked using the Side Effect Checklist for ziprasidone, which is a well-validated 17 item scale that records the presence or absence of side effects. Total number of side effect events is reported here.
From Baseline up to Week 8
Change From Baseline in Simpson Angus Scale for Extrapyramidal Symptoms (SAS)
The SAS is a 10-item testing instrument used to evaluate drug-related extrapyramidal syndromes. The following items are included in the SAS: gait, arm dropping, shoulder shaking, elbow rigidity, wrist rigidity, leg pendulousness, head dropping, glabella reflex, tremor, and salivation. Total score ranges from 0 to 40 with a higher score indicating increased severity. A positive change from baseline indicates a worse outcome.
Baseline, Week 2, Week 4, Week 6, Week 8
Change From Baseline in the Barnes Akathisia Scale (BAS)
BAS is a rating scale that is administered by physicians to assess the severity of drug-induced akathisia, which is a movement disorder characterized by a feeling of inner restlessness and a compelling need to be in constant motion, as well as by actions such as rocking while standing or sitting, lifting the feet as if marching on the spot, and crossing and uncrossing the legs while sitting. The following subcategories are scored: objective akathisia, subjective awareness of restlessness and subjective distress related to restlessness and are rated on a 4-point scale from 0 - 3. In addition, the global clinical assessment of akathisia uses a 6-point scale ranging from 0 - 5. Total score ranges from 0 to 14 with a higher score indicating increased severity. A positive change from baseline indicates a worse outcome.
Baseline, Week 2, Week 4, Week 6, Week 8
Change From Baseline in Positive Subscale Score of PANSS
Baseline, Week 2, Week 4, Week 6, Week 8
Change From Baseline in PANSS Negative Subscale Score
Baseline, Week 2, Week 4, Week 6, Week 8
Change From Baseline in the Calgary Depression Rating Scale (CDRS) Total Score
Baseline, Week 2, Week 4, Week 6, Week 8
Change From Baseline in Clinical Global Impression- Severity (CGI-S) Score
Baseline, Week 8
Change From Baseline in Clinical Global Impression - Improvement (CGI-I) Score
Baseline, Week 8
Participants with schizophrenia or schizoaffective disorder who remain symptomatic despite treatment with ziprasidone 160 mg/d for at least 3 weeks will be instructed to take ziprasidone oral capsule twice daily added to their regular open-label ziprasidone dose (total of 240 mg/d). After the first week, the study drug will be increased to a total ziprasidone dose of 320 mg/d for 7 weeks.
Participants with schizophrenia or schizoaffective disorder who remain symptomatic despite treatment with ziprasidone 160 mg/d for at least 3 weeks will be instructed to take matching placebo oral capsule twice daily added to their regular open-label ziprasidone dose of 160 mg/d. After the first week, the matching placebo will be increased to two capsules twice daily and their regular open-label ziprasidone will remain the same (160 mg/d) for 7 weeks.
Participants will be instructed to take one study capsule of ziprasidone orally twice daily (80 mg/d). After the first week, the study drug will be increased to two capsules twice daily (160 mg/d).
Participants will be instructed to take one study capsule of matching placebo orally twice daily. After the first week, the matching placebo will be increased to two capsules twice daily.
Medical College of Georgia
Augusta, Georgia, 30912, United States
Corrigan Mental Health Center
Fall River, Massachusetts, 02720, United States
Touchstone innovare
Grand Rapids, Michigan, 49503, United States
University of New Mexico
Albuquerque, New Mexico, 87131, United States
SUNY Downstate Medical Center
Brooklyn, New York, 11203, United States
The Lieber Center for Schizophrenia Research - Columbia University
New York, New York, 10032, United States
Nathan Kline Institute
Orangeburg, New York, 10962, United States
Donald Goff, M.D.
Massachusetts General Hospital
131 participants (actual enrollment reported by the registry).
First Submitted
November 21, 2006
First Posted
November 23, 2006
Study Start
January 2006
Actual (reported)Extension Study: Evaluating the Safety of Oral Ziprasidone in the Treatment of Subjects With Schizophrenia
Number of Participants With High and Low Levels in Serum Prolactin Concentration
Blood samples were taken at baseline and Week 8 to measure serum prolactin concentrations. Normal range for females (non-pregnant) is 2-29 nanograms per deciliter (ng/dL) and for males 2-18 ng/dL. Values above the normal range were reported as High and values below the normal range were reported as Low. Reported here is the number of participants with high prolactin concentration and the number of participants with low prolactin concentration.
Baseline, Week 8
Vital Signs: Systolic and Diastolic Blood Pressure Levels
Systolic blood pressure (SBP) and diastolic blood pressure (DBP) were measured at regular times during the study. Normal SBP is defined as 120 millimeters of mercury (mmHg) or below and normal DBP is defined as 80 mmHg or below. Change from baseline is indicated for each time point. A positive change from baseline indicates and increase in blood pressure and a negative change from baseline indicates a decrease.
Baseline, Week 1, Week 2, Week 4, Week 6, Week 8
Electrocardiogram (EKG): Number of Participants With an Increase From Baseline to Corrected QT (QTc) Interval >/= 500 Milliseconds (Msec)
QT interval is a measure of the time between the start of the Q wave and the end of the T wave as determined by electrocardiogram (EKG). The corrected QT Interval (QTc) adjusts the QT interval for heart rate. The number of participants with an increase to QTc interval \>/= 500 msec was reported.
6 hours after dosing of Weeks 1, 2 and 8
Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score
The PANSS is a medical scale and was used for measuring symptom severity of participants with schizophrenia in this study. Total PANSS score consists of 7 items in the Negative subscale, 7 items in the Positive subscale and 16 items in the General Psychopathology scale. Total PANSS score ranges from 30 to 210. A higher score indicates a worse outcome. A negative change from baseline indicates an improvement.
Baseline, Week 2, Week 4, Week 6, Week 8
Percentage of Participants With Response
Response was defined as a reduction in the PANSS total score from baseline by 20% or greater, calculated by first subtracting 30 (the PANSS minimum possible total score). Response rate is the percentage of participants with a response.
Baseline, Week 2, Week 4, Week 6, Week 8
Change From Baseline in Abnormal Involuntary Movement Scale (AIMS) Score
AIMS is a rating scale measuring involuntary movements known as tardive dyskinesia, that sometimes develop as a side effect of long-term treatment with antipsychotic medications. The AIMS score was calculated as the sum of questions 1 through 7 of the AIMS instrument, which includes assessments of involuntary movements in the face, lips, jaw, tongue, upper and lower extremities, and neck/shoulders/hips. Each item is rated on a five-point scale of severity from 0-4 with 0 (none), 1 (minimal), 2 (mild), 3 (moderate), 4 (severe). Total scores range from 0 to 28. A negative change from baseline indicates an improvement.
Baseline, Week 2, Week 4, Week 6, Week 8
Number of Treatment-emergent Adverse Events During Randomized Trial
Adverse event: any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as adverse events. Serious adverse event (SAE): significant hazard, contraindication, side effect, or precaution, which fulfilled any of the following criteria: fatal (resulted in death), life-threatening, required in-patient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, was medically significant or required intervention to prevent any of the other outcomes listed here.
From Baseline up to Week 8
Participants will be taking open-label ziprasidone 80 mg orally twice daily for a total dose of 160 mg/d from at least 3 weeks before randomization to end of study 8 weeks after randomization.
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Duke University - John Umstead Hospital
Butner, North Carolina, 27509, United States
The Mech Center
Plano, Texas, 75024, United States
Primary Completion
May 2011
Actual (reported)Study Completion
May 2011
Actual (reported)Last Updated
June 6, 2017
Results First Posted
June 6, 2017
Record last verified: 2017-06
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Source: ClinicalTrials.gov.
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