A SIXTEEN-WEEK, MULTI-CENTER, OPEN-LABEL STUDY EVALUATING THE SAFETY, TOLERABILITY, AND EFFICACY OF SWITCHING FROM QUETIAPINE TO ZIPRASIDONE IN SUBJECTS DIAGNOSED WITH SCHIZOPHRENIA OR SCHIZOAFFECTIVE DISORDER - N/A

• Register: EUCTR
• Last refreshed on: 24 January 2022
• Main ID: EUCTR2006-003475-13-GR
• Date of registration: 24/11/2006
• Prospective Registration: Yes
• Primary sponsor: Pfizer Hellas AE
• Public title: A SIXTEEN-WEEK, MULTI-CENTER, OPEN-LABEL STUDY EVALUATING THE SAFETY, TOLERABILITY, AND EFFICACY OF SWITCHING FROM QUETIAPINE TO ZIPRASIDONE IN SUBJECTS DIAGNOSED WITH SCHIZOPHRENIA OR SCHIZOAFFECTIVE DISORDER - N/A
• Scientific title: A SIXTEEN-WEEK, MULTI-CENTER, OPEN-LABEL STUDY EVALUATING THE SAFETY, TOLERABILITY, AND EFFICACY OF SWITCHING FROM QUETIAPINE TO ZIPRASIDONE IN SUBJECTS DIAGNOSED WITH SCHIZOPHRENIA OR SCHIZOAFFECTIVE DISORDER - N/A
• Date of first enrolment: 27/03/2007
• Target sample size: 250
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2006-003475-13
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes; Randomised: no; Open: yes; Single blind: no; Double blind: no; Parallel group: no; Cross over: no; Other: no; If controlled, specify comparator, Other Medicinial Product: no; Placebo: no; Other: no
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): no Therapeutic use (Phase IV): yes

Countries of recruitment

Germany, Greece

Key inclusion & exclusion criteria

Inclusion criteria:
Subjects must meet all of the following inclusion criteria to be eligible for enrollment into the trial:
General Inclusion Criteria
1. Males or females, between 18 and 55 years of age, at the time of consent
2. Be a female who is not of child-bearing potential (i.e. surgically sterile or postmenopausal for at least one year), or be non-pregnant and be established on an acceptable method of birth control or be one who abstains from sex. Female subjects must meet all of the following criteria:
a. Agree to avoid pregnancy during the study and
b. Have a negative serum pregnancy test (ß-HCG) at screening and
c. Use one of the birth control methods listed below for the duration of the trial. Preferred methods of birth control include:
• An oral contraceptive agent, implantable contraceptive (e.g., Norplant) or an injectable contraceptive (e.g., Depo Provera) for at least one month prior to entering the study or prior to having sexual relations during the study and will continue its use throughout the study, or
• An intrauterine device, or
• Partner has had a vasectomy at least 3 months prior to study start
Also Allowed:
• A double-barrier method of a diaphragm with spermicide, plus a latex condom, or
• Agree to abstain from sex for the duration of the trial.
Note: complete abstinence will be considered on a case-by-case basis, but must first be reviewed and approved by the Sponsor-designated physician
3. Subjects must be capable of reading at or above a 6th grade level
4. Subjects must be willing and able to comply with study treatments, scheduled visits, and laboratory tests.
5. Prior to participation in any study procedures, subjects must provide informed consent which is signed, dated, and witnessed, indicating that they have been informed of all pertinent benefits and risks of study participation and study procedures.
Psychiatric Inclusion Criteria
6. Subjects must have a primary diagnosis of schizophrenia, any subtype (295.xx), or schizoaffective disorder as defined in DSM-IV-TR™
7. Subjects must have been treated as outpatients with oral doses of quetiapine in the range of 150-750 mg/day for a minimum of three months; subjects in day hospitals and supervised living situations will be allowed to participate
8. Subjects must have achieved only a partial response to treatment with quetiapine, or have experienced troublesome side effects (sedation, weight gain, etc.) attributed to treatment with quetiapine
Medical Inclusion Criteria
1. Subjects must have normal vital signs, physical examination, ECG, and laboratory findings except for minor deviations determined and documented to be clinically insignificant by the investigator or a sub-investigator who is a medical doctor.
2. Subjects must have a urine drug screen negative for illicit drugs; at the discretion of the investigator, subjects positive for cannabinoids or benzodiazepines may be admitted upon sponsor approval.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion criteria:
General Exclusion Criteria
1. Subjects who are unable to provide informed consent
2. Subjects who have a history of repeated non-compliance with treatment
3. Subjects with contraindications according to the local prescribing information of Ziprasidone
Psychiatric Exclusion Criteria
1. Subjects who meet criteria for a DSM-IV-TR™ Axis I diagnosis other than schizophrenia or schizoaffective disorder, including psychoactive substance abuse or dependence within one year of study entry
2. Subjects who are known to have ingested phencyclidine within 60 days of study entry
3. Subjects who have been treated with antiepileptic drugs such as valproate, diphenylhydantoin, or carbamazepine within 30 days of study entry, even if used for augmentation of antipsychotic drugs
4. Subjects who have been treated within 30 days of study entry with any psychoactive medication other than quetiapine, p.r.n. benzodiazepine, p.r.n. diphenhydramine, p.r.n. hypnotic, or antiparkinsonian medication (benztropine, trihexiphenidyl, or amantadine)
5. Subjects with a history of suicide attempt who develop significant depression, acute suicidal ideation, or who attempt suicide during the study, will be discontinued from the study and provided with treatment (or an appropriate referral) by the investigator.
6. Subjects judged by the investigator based on history, mental status exam, or investigator judgment as being at significant risk of self-injurious/suicidal or violent/homicidal behavior
7. Subjects with a history of treatment resistance, defined as the presence of severe symptoms despite adequate trials with more than two other typical or atypical antipsychotics. Subjects who have failed to respond to quetiapine, or those who discontinued treatment primarily as a result of being unable to tolerate side effects (e.g., having seizures, agranulocytosis, excessive weight gain) may be included.
8. Subjects who are receiving quetiapine at a dose of less than 150 mg/day, or any dose for less than 3 months.
9. Subjects who have received depot antipsychotic medication within 30 days of enrollment. Subjects that received depot neuroleptic treatment may be included as long as the subject terminated treatment with the depot antipsychotic medication and has been treated with quetiapine for at least 3 months prior to Screening.
10. Subjects who have ever been discontinued from ziprasidone treatment due to lack of efficacy or significant adverse event(s).
Medical Exclusion Criteria
1. Females who are pregnant, breast feeding, or lactating at screening.
2. Females of childbearing potential who are unwilling or unable to use adequate contraception to prevent pregnancy during the program.
3. Subjects who have a history of chronic hepatitis
4. Subjects with a known history of Acquired Immune Deficiency Syndrome (AIDS), or who have previously tested seropositive for human immunodeficiency virus (HIV) antibody or antigen.
5. Subjects who have used any other investigational drug for 3 months preceding or at any time during the study
6. Subjects who have used, or are schedule to receive, any concomitant medications not allowed by the Concomitant Medication Table
7. Subjects with any medical condition, medication, or dietary habit that may confound the evaluation of the study drug
8. Subjects with any unstable or untreated medical illness.
9. Subjects who have a medical condition that would interfere with assessments of efficacy or safety, or expose them to an increased risk of signifi

Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Schizophrenia and Schizoaffective Disorder
MedDRA version: 8.1 Level: LLT Classification code 10039635 Term: Schizophrenia schizoaffective

Intervention(s)

Trade Name: GEODON 20 mg
Pharmaceutical Form: Capsule*
INN or Proposed INN: Ziprasidone Hydrochloride
CAS Number: 146939-27-7
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 20-

Trade Name: GEODON 60 mg
Pharmaceutical Form: Capsule*
INN or Proposed INN: Ziprasidone Hydrochloride
CAS Number: 146939-27-7
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 60-

Primary Outcome(s)

Primary end point(s): Unless otherwise specified, endpoints are calculated as the change in a parameter between Baseline and Week 16.
The primary endpoint of the study is the change in weight (kg) at Week 16.
Secondary safety endpoints consist of the following:
• Fasting lipid profile (total cholesterol)
• HDL, LDL and Triglycerides
• Hb A1c
• Fasting glucose and insulin
• Waist and hip circumference
• Abnormal Involuntary Movement Scale (AIMS)
• Spontaneously reported adverse events during the study
• Subjects reporting any adverse event during the study
• Subjects reporting a mild, moderate, or severe adverse event during the study
• Subjects discontinuing due to an adverse event during the study
• Subjects who develop clinically significant abnormalities in blood chemistries, hematologies, or ECG parameters during the study
Secondary efficacy endpoints consist of the following:
• Positive and Negative Symptoms of Schizophrenia (PANSS) total score and
positive and negative subscale scores
• Clinical Global Impression, Improvement Scale (CGI-I) change from Clinical Global
Impression, Severity Scale (CGI-S)
• Calgary Depression Scale for Schizophrenia (CDSS)
• Schizophrenia Cognition Rating Scale (SCoRS)
• Global Assessment of Function Scale (GAF)
• Treatment Satisfaction Questionnaire for Medication (TQSM)

Main Objective: The primary objective of this study is to evaluate change in weight as a result of switching to ziprasidone, in subjects who have failed to achieve a satisfactory clinical response to quetiapine due to lack of efficacy or poor tolerability.

Secondary Objective: The secondary objectives of this study are to evaluate the effect on additional safety parameters (glucose and lipid metabolism) and efficacy parameters.

Secondary ID(s)

A1281148

2006-003475-13-DE

N/A

Ethics review

Status: Approved
Approval date: 27/03/2007
Contact:

Results

• Results available: Yes
• Date Posted: 12/02/2015
• Date Completed: 31/03/2009
• URL: https://www.clinicaltrialsregister.eu/ctr-search/trial/2006-003475-13/results