Schizophrenia and Schizoaffective Disorder MedDRA version: 8.1 Level: LLT Classification code 10039635 Term: Schizophrenia schizoaffective
Conditions
Interventions
Trade Name: Zeldox 20 mg Hartkapseln
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: Ziprasidone
CAS Number: 146939-27-7
Other descriptive name: 5-[2-[4-(1,2-benzisothiazol-3-yl)-1-piperazinyl
Sponsors
Pfizer Pharma GmbH
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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. 3. Subjects must be willing and able to comply with study treatments, scheduled visits, and laboratory tests. 4. Prior to participation in any study procedures, subjects must have read and understood the informed consent which is then signed and dated, indicating that they have been informed of all pertinent benefits and risks of study participation and study procedures. Psychiatric Inclusion Criteria 1. Subjects must have a primary diagnosis of schizophrenia, any subtype (295.xx), or schizoaffective disorder as defined in DSM-IV-TR™ 2. Subjects must have been treated with oral doses of quetiapine, consistent with medical practice, at a minimum of 300 mg per day for at least three months 3. Subjects must have failed to respond to quetiapine due to lack of efficacy or intolerable side effects 4. Subjects must be treated as outpatients at the time of enrollment; however, subjects in day hospitals and supervised living situations will be allowed to participate. 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 negative urine drug screen for illicit drugs. At the discretion of the investigator, subjects positive for cannabinoids 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
Exclusion criteria: Subjects … • unable to provide informed consent • with a history of repeated non-compliance with treatment • with contraindications according to the local prescribing information of Ziprasidone • meeting criteria for an active DSM-IV-TR™ Axis I diagnosis (including psychoactive substance abuse or dependence) other than schizophrenia or schizoaffective disorder within 1 year of study entry • known to have ingested phencyclidine within 60 days of study entry • treated within any of the following psychotropic medications; any oral antipsychotic drug (other than quetiapine), tricyclic antidepressants, MAOIs, modafinil, pregabalin, topiramate and zonisamide. Patients on any of these medications require at least a 7 day washout period prior to baseline (visit 2, week 0), except MAOIs (that require at least 14 day washout). • who’ve received depot antipsychotic medication within 30 days of study entry. 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. • judged by the investigator (based on history, mental status exam, or clinical impression) as being at significant risk of self-injurious/suicidal or violent/homicidal behavior. Subjects 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. • with a history of treatment resistance, defined as the presence of severe symptoms despite adequate trials with more than two typical or atypical antipsychotics (other than quetiapine), or subjects who have been treated with clozapine. • who are receiving quetiapine at a dose of less than 300 mg/day, or any dose for less than 3 months. • ever discontinued from ziprasidone treatment due to significant adverse event(s). • Females who are pregnant, breast feeding, or lactating at screening. • Females of childbearing potential who are unwilling or unable to use adequate contraception to prevent pregnancy during the study. • having a history of chronic hepatitis • with a known history of AIDS, or who have previously tested seropositive for HIV antibody or antigen. • having used, or are schedule to receive, any medications not allowed by Appendix C • with any medical condition, medication, or dietary habit that may confound the evaluation of the study drug • with any unstable or untreated medical illness • who have a medical condition that would interfere with assessments of efficacy or safety, or expose them to an increased risk of significant adverse events, including but not limited to cardiovascular, neurologic, endocrine, hepatic, respiratory, renal, or hematologic disease per investigator judgment. • with a history of seizures (except febrile seizures of childhood), epilepsy, or a history of a clinically significant abnormal EEG, or if currently being treated for a seizure disorder. • with thyroid pathology, or any thyroid hormone test abnormality (including but not limited to hypothyroidism or hyperthyroidism), unless the subject has been stabilized on medications for the past 3 months. The entry into the study of subjects who have minor thyroid hormone test abnormalities must first be discussed with the sponsor. • with a QTc interval >500 msec (Bazett correction) at the screening or baseline visit; or subjects with a
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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.;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) | — |
Countries
Germany, Greece
Outcome results
None listed