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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT00265382
Other study ID # A1281135
Secondary ID
Status Terminated
Phase Phase 3
First received
Last updated
Start date June 2006
Est. completion date June 2009

Study information

Verified date March 2021
Source Pfizer
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of this study is to assess the safety and tolerability of ziprasidone during long-term open-label administration in adolescents (ages 13-17) with schizophrenia.


Description:

On March 24, 2009, Pfizer Inc. stopped late stage Geodon pediatric clinical trials in schizophrenia (A1281134 - placebo controlled; A1281135 - open label). As recommended by the DSMB, these studies were stopped due to lack of efficacy. No safety concerns were identified.


Recruitment information / eligibility

Status Terminated
Enrollment 221
Est. completion date June 2009
Est. primary completion date June 2009
Accepts healthy volunteers No
Gender All
Age group 13 Years to 17 Years
Eligibility Inclusion Criteria: - Participation in double-blind treatment study A1281134, meeting specific criteria of duration and safety Exclusion Criteria: - Imminent risk of suicide or homicide, as judged by the site investigator - Serious adverse event related to study medication in study A1281134 - Significant prolongation of QT interval in study A1281134

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Ziprasidone oral capsules
Study medications will include oral ziprasidone capsules of 20 mg, 40 mg, 60 mg, and 80 mg strength. Subjects will be dosed daily for 26 weeks using a flexible dose design with a minimal dose range of 20mg bid to a maximum dose range of 80 mg bid.

Locations

Country Name City State
Colombia Pfizer Investigational Site Bello Antioquia
Colombia Pfizer Investigational Site Bogota Cundinamarca
Costa Rica Pfizer Investigational Site San Jose
India Pfizer Investigational Site Ahmedabad Guj
India Pfizer Investigational Site Aurangabad Maharashtra
India Pfizer Investigational Site Chennai Tamil Nadu
India Pfizer Investigational Site Ludhiana Punjab
India Pfizer Investigational Site Mangalore Karnataka
India Pfizer Investigational Site Mumbai Maharashtra
India Pfizer Investigational Site Pune Maharashtra
India Pfizer Investigational Site Pune Maharashtra
India Pfizer Investigational Site Vijaywada Andhra Pradesh
Malaysia Pfizer Investigational Site Kuala Lumpur
Malaysia Pfizer Investigational Site Kuala Lumpur
Malaysia Pfizer Investigational Site Kuala Lumpur
Malaysia Pfizer Investigational Site Kubang Kerian Kelantan
Peru Pfizer Investigational Site Lima
Peru Pfizer Investigational Site Lima
Russian Federation Pfizer Investigational Site Kazan
Russian Federation Pfizer Investigational Site Lipetsk Region Russia
Russian Federation Pfizer Investigational Site Moscow
Russian Federation Pfizer Investigational Site Moscow
Russian Federation Pfizer Investigational Site Moscow
Russian Federation Pfizer Investigational Site Moscow
Russian Federation Pfizer Investigational Site Nizhniy Novgorod
Russian Federation Pfizer Investigational Site Saratov
Russian Federation Pfizer Investigational Site Saratov
Russian Federation Pfizer Investigational Site Tver
Russian Federation Pfizer Investigational Site Yaroslavl
Singapore Pfizer Investigational Site Singapore
Singapore Pfizer Investigational Site Singapore
Ukraine Pfizer Investigational Site Dnipropetrovsk
Ukraine Pfizer Investigational Site Dnipropetrovsk
Ukraine Pfizer Investigational Site Donetsk
Ukraine Pfizer Investigational Site Kharkiv
Ukraine Pfizer Investigational Site Kyiv
Ukraine Pfizer Investigational Site Lugansk
Ukraine Pfizer Investigational Site Lviv
Ukraine Pfizer Investigational Site Odess
Ukraine Pfizer Investigational Site Poltava
Ukraine Pfizer Investigational Site Simferopol Crimea
Ukraine Pfizer Investigational Site Vinnytsya
United States Pfizer Investigational Site Altamonte Springs Florida
United States Pfizer Investigational Site Birmingham Alabama
United States Pfizer Investigational Site Birmingham Alabama
United States Pfizer Investigational Site Birmingham Alabama
United States Pfizer Investigational Site Bothell Washington
United States Pfizer Investigational Site Bridgeton Missouri
United States Pfizer Investigational Site Buffalo New York
United States Pfizer Investigational Site Cincinnati Ohio
United States Pfizer Investigational Site Cincinnati Ohio
United States Pfizer Investigational Site Cincinnati Ohio
United States Pfizer Investigational Site Cleveland Ohio
United States Pfizer Investigational Site Clinton Township Michigan
United States Pfizer Investigational Site Denver Colorado
United States Pfizer Investigational Site Des Plaines Illinois
United States Pfizer Investigational Site Oakbrook Terrace Illinois
United States Pfizer Investigational Site Oklahoma City Oklahoma
United States Pfizer Investigational Site Oklahoma City Oklahoma
United States Pfizer Investigational Site Orange City Florida
United States Pfizer Investigational Site Rochester New York
United States Pfizer Investigational Site Saint Louis Missouri
United States Pfizer Investigational Site San Diego California
United States Pfizer Investigational Site Schaumburg Illinois
United States Pfizer Investigational Site Smyrna Georgia
United States Pfizer Investigational Site Spokane Washington
United States Pfizer Investigational Site Tucker Georgia
United States Pfizer Investigational Site Washington District of Columbia

Sponsors (1)

Lead Sponsor Collaborator
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

Countries where clinical trial is conducted

United States,  Colombia,  Costa Rica,  India,  Malaysia,  Peru,  Russian Federation,  Singapore,  Ukraine, 

Outcome

Type Measure Description Time frame Safety issue
Primary Number of Subjects With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) All observed or volunteered treatment-emergent AEs and SAEs regardless of treatment group or suspected causal relationship to the investigational product(s) were reported. 26 weeks
Secondary Number of Subjects With Change From Baseline to Each Pubertal Stage of Development as Assessed by the Tanner Adolescent Pubertal Self Assessment Tanner Adolescent Pubertal Staging Questionnaire: used to document the stage of development of secondary sexual characteristics. Female pubertal development staged by pubic hair development and breast size; males pubertal development staged by size of the genitalia and development of pubic hair. Rated in 5 stages: stage 1 (no development) to 5 (adult-like development in quantity and size). Baseline, Week 26, Early Termination (ET)
Secondary Change From Baseline in Children's Problem Behavior and Aggression Questionnaire (CPBAQ) Total Score CPBAQ: 19-item parent or legal guardian completed questionnaire to rate the child's verbal (such as yelling or cursing) and physical aggression (such a fighting with peers or being cruel to an animal) during the past week. Behavior was rated on a 4-point scale; range 0 (behavior did not occur or was not a problem) to 3 (behavior occurred a lot or was severe problem). Total score range 0 to 57; higher scores indicate a greater frequency and severity of aggression. Baseline, Weeks 2, 6, 18, 26, ET
Secondary Change From Baseline in Child Depression Rating Scale - Revised (CDRS-R): Total Score CDRS-R: clinician-rated interview-based scale (with both child and parent or guardian) to assess 17 distinct symptom areas to derive an index of depression severity. Discrepancies between informants' responses were resolved by using most impaired rating given by valid informant. Rated on a 7-point scale; range from 1 (no impairment) to 7 (indicates greater impairment). Total score calculated as sum of the 17 items (range 1 to 119); higher score indicates greater impairment. Baseline, Weeks 1, 2, 6, 10, 14, 18, 22, 26, ET
Secondary Change From Baseline in CNS Vital Signs Cognitive Test Battery (Includes Sedation Item): Subscales Computerized subject-administered test battery with subtests for verbal and visual memory, processing speed, nonverbal reasoning, executive functioning, working memory, sustained attention. Computerized 7- point sedation item (0 [not sleepy] to 10 [very sleepy]) was completed prior to test battery. Neurocognitive index score was derived from subtest scores per an algorithm. Index score and subtest scores assessed the subject's changes in cognition. Scores were rated as above average (score >109), average (90 to 109), below average (80 to 89), or well below average (70 to 79). Baseline, Weeks 6 and 26, ET
Secondary Change From Baseline in CNS Vital Signs Cognitive Test Battery: Neurocognitive Index Computerized subject-administered test battery with subtests for verbal and visual memory, processing speed, nonverbal reasoning, executive functioning, working memory, sustained attention. Computerized 7- point sedation item (0 [not sleepy] to 10 [very sleepy]) was completed prior to test battery. Neurocognitive index score was derived from subtest scores per an algorithm. Index score and subtest scores assessed the subject's changes in cognition. Scores were rated as above average (score >109), average (90 to 109), below average (80 to 89), or well below average (70 to 79). Baseline, Weeks 6 and 26, ET
Secondary Change From Baseline in Simpson-Angus Rating Scale (SARS) SARS: 10-item clinician rated instrument to assess parkinsonian symptoms (7 items) and related extrapyramidal side effects (3 items): gait, arm dropping, shoulder shaking, elbow rigidity, leg pendulousness, glabellar tap, tremor, and salivation. Head dropping (modified SARS item 7) substituted for head rotation. Anchored 5-point scale: range 0 (absence of condition, normal) to 4 (most extreme form of condition). Total score is sum of individual item scores (range 0 to 40); higher score indicates more affected. Baseline, Weeks 1, 2, 6, 10, 14, 18, 22, 26, ET
Secondary Change From Baseline in Barnes Akathisia Rating Scale (BAS) Global Clinical Assessment Item BAS: clinician rated scale to assess akathisia to determine the degree of subjective restlessness and distress associated with restlessness. First 3 items (Objective, Subjective, and Distress related to restlessness) rated on a 4-point scale with range 0 (no symptoms) to 3 (increased severity of symptoms). Item 4 Global Clinical Assessment of Akathisia rated on a 6- point scale range 0 (no symptoms) to 5 (increased severity of symptoms); higher score indicates increased severity. All rating are anchored. Only the Global Clinical Assessment of Akathisia was to be analyzed. Baseline, Weeks 1, 2, 6, 10, 14, 18, 22, 26, ET
Secondary Change From Baseline in Abnormal Involuntary Movement Scale (AIMS) Movement Cluster Score AIMS: clinician rated 12-item scale to rate 7 body areas and global judgments on the severity of abnormal movements, incapacitation and subject's awareness of abnormal movements. Items 1 to 10 scored 0 (none) to 4 (severe) (total possible score 0 to 40; higher score indicates greater severity); items 11 to 14 are No or Yes response to dental status and sleep movements. Only the sum of the first 7 items to be analyzed (AIMS Movement Cluster score). Total score 0 to 28; higher score indicates greater severity. Baseline, Weeks 1, 2, 6, 10, 14, 18, 22, 26, ET
Secondary Change From Baseline in Brief Psychiatric Rating Scale - Anchored (BPRS-A) Total Score BPRS-A: 18-item clinician rated scale to assess somatic concern, anxiety, emotional withdrawal, disorganization, hallucinatory behavior, guilt feelings, suspiciousness, disorientation, tension, mannerisms, posturing, grandiosity, depressive mood, hostility, motor retardation, uncooperativeness, unusual thought content, blunted affect, excitement. Ratings anchored to improve consistency for single rater over time or between raters. Items rated on 7-point scale 0 (not present) to 6 (extremely severe). Total score=sum of items (range 0 to 108); higher scores indicate increased pathology. Baseline, Weeks 2, 6, 18, 26, ET
Secondary Change From Baseline in Children's Global Assessment Scale (CGAS) CGAS: clinician-rated global assessment item for children based on symptoms and social functioning in home, school, and community settings. Scores on this single item range from 1 to 100 (higher levels indicate greater health) with descriptive anchors for every 10-point interval. Scores above 70 on this scale are considered within the "normal" range; lower score indicates need for increased supervision. Baseline, Weeks 2, 6, 18, 26, ET
Secondary Change From Baseline in Child Health Questionnaire (CHQ) CHQ: 50-item, 15 subscale parent or legal guardian assessed instrument of child's physical, emotional, social well-being, and relative burden of disease on the parents; rated on Likert-type scale: range 0 to 100; higher scores indicate a more positive health status. Global indicators for Physical Health and Psychosocial Health are weighted composites derived from subscale items using scoring algorithms (transformed scores); range 0 to 100: higher scores indicate more positive health status. Baseline, Weeks 6 and 26, ET
Secondary Number of Subjects Per Response on the School Placement Questionnaire: School Situation School placement questionnaire: parent or legal guardian assessed questionnaire to determine whether the child is currently enrolled in school (or planned to be enrolled if on school holiday like summer break), whether attending regularly if enrolled, and how well the child is doing overall in school. Questions were modified from those used in the National Institute of Mental Health (NIMH) funded Treatment of Early Onset Schizophrenia Spectrum (TEOSS) study. Results determine whether subjects are currently attending school and qualitatively describe how well they are doing in school. Baseline, Weeks 6 and 26, ET
Secondary Number of Subjects Per Response on the School Placement Questionnaire: School Attendance School placement questionnaire: parent or legal guardian assessed questionnaire to determine whether the child is currently enrolled in school (or planned to be enrolled if on school holiday like summer break), whether attending regularly if enrolled, and how well the child is doing overall in school. Questions were modified from those used in the National Institute of Mental Health (NIMH) funded Treatment of Early Onset Schizophrenia Spectrum (TEOSS) study. Results determine whether subjects are currently attending school and qualitatively describe how well they are doing in school. Baseline, Weeks 6 and 26, ET
Secondary Number of Subjects Per Response on the School Placement Questionnaire: Overall School Performance School placement questionnaire: parent or legal guardian assessed questionnaire to determine whether the child is currently enrolled in school (or planned to be enrolled if on school holiday like summer break), whether attending regularly if enrolled, and how well the child is doing overall in school. Questions were modified from those used in the National Institute of Mental Health (NIMH) funded Treatment of Early Onset Schizophrenia Spectrum (TEOSS) study. Results determine whether subjects are currently attending school and qualitatively describe how well they are doing in school. Baseline, Weeks 6 and 26, ET
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