A Randomized, Multicenter, Double-blind, Parallel Group Study ToCompare the Effects of Bifeprunox and Quetiapine on WeightChanges in Stable Schizophrenic Patients.
- Conditions
- MedDRA version: 8.1Level: LLTClassification code 10039626Term: Schizophreniaschizophrenia
- Registration Number
- EUCTR2006-004973-83-EE
- Lead Sponsor
- Solvay Pharmaceuticals. Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 875
The subject or subject’s authorized legal representative must understand the nature of the study
and must provide written informed consent prior to conduct of any study procedures.
2. Each subject must be able to communicate with study personnel.
3. Current Diagnostic and Statistical Manual of Mental Disorders, 4th Edition, Text Revision
(DSM-IV TR) primary diagnosis of Schizophrenia (codes 295.10, 295.20, 295.30, 295.60,
295.90).
4. No hospitalization for an exacerbation of schizophrenia within two months prior to screening
and during the screening period.
5. No change in antipsychotic medication(s) and doses within eight weeks prior to screening and
during the screening period.
6. Normal physical and neurological examination, medical history, electrocardiogram, blood
biochemistry, hematology test, vital signs at screening supportive of general good health at the
discretion of the Investigator.
7. Male or female subjects who are between 18-65 years, inclusive.
8. PANSS total score = 80 at screening and baseline.
9. Subjects who have a CGI-S score of = 4 (moderately ill) at screening and baseline.
10. Subjects who have a score of = 4 (moderate) of the following PANSS items at screening and
baseline:
- P2 (conceptual disorganization)
- P3 (hallucinatory behavior)
- P6 (suspiciousness/persecution)
- P7 (hostility)
- G8 (uncooperativeness)
- G9 (unusual thought content)
11. Subjects who have a BMI > 27 kg/m2 at screening.
12. Subjects who have a fasting triglyceride level > 130 mg/dl at screening.
13. Females who are not breast-feeding or are of non-childbearing potential. All females must have
a negative serum ß-HCG test prior to baseline. Non-childbearing is defined as:
• last natural menstruation at least 24 months prior to screening, or
• surgically sterilized (i.e. tubal sterilization), or
• hysterectomized state.
A female subject of child-bearing potential may be enrolled provided that she is maintained on
one of the following medically acceptable methods of birth control:
• oral or patch contraception at a stable dose for at least three months prior to screening
• the first dose of medroxyprogesterone (Depo-Provera?) or other intramuscular injection
administrated at least two months prior to screening and have been maintaining the
recommended administration schedule
• implantation of levonorgestrel (Norplant?) system or an IUD for at least two months
prior to screening
• barrier methods (combination of diaphragm and spermicide or condom and spermicide)
prior to screening and during the trial.
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
Current active acute psychotic episode or a current Axis I primary psychiatric diagnosis other
than schizophrenia based on DSM-IV TR criteria.
2. The potential for violent behavior (likely to harm themselves or others) based on history and
mental status examination, or Investigator’s judgment.
3. Suicidal ideation within the 12 months prior to screening or who have attempted suicide within
3 years prior to screening.
4. Unstable medical, psychiatric, neurological or behavioral disorders that may interfere with the
conduct or interpretation of the study.
5. A history of moderate or severe head trauma or other neurological disorders and systemic
medical diseases which are likely to affect the central nervous system functioning.
6. Malignant disease or a history of malignant disease, other than adequately treated carcinoma in
situ of the cervix or basal cell carcinoma of the skin, within the past five years prior to
screening.
7. Current diagnosis or history of substance (except nicotine, caffeine) or alcohol abuse based on
DSM-IV TR criteria within six months prior to screening.
8. Positive urine drug screen at screening, baseline and/or during the study. Positive result for
opioids and cannabinoids will be evaluated by the Investigator and Medical Monitor on the
potential impact and continued participation of the subject in the study.
9. Exposure to any investigational drug within 60 days prior to screening.
10. Treatment with bifeprunox in a previous study.
11. Treatment with clozapine within 60 days prior to screening.
12. Current treatment with depot antipsychotic medication.
13. Treatment with electroconvulsive therapy (ECT) within 12 weeks prior to screening.
14. Prior treatment with quetiapine within one year prior to screening.
15. History of intolerance or failed to respond to previous treatment with quetiapine.
16. Treatment with antidepressants or mood stabilizers within 2 months prior to screening.
Solvay Pharmaceuticals, Inc. Protocol No. S154.3.021
25 Protocol Date 28 July 2006
17. Subjects who require disallowed concomitant medications (specified in Table 2) during the
study. All allowed concomitant medications are preferably to be maintained at the same dose
level throughout the study.
18. Current evidence of clinically significant, untreated or uncontrolled neurological,
hematological, autoimmune, endocrine, cardiovascular, liver, renal, gastrointestinal, pulmonary
or infectious disease, or metabolic disturbances other than those originating from the
antipsychotic treatment that would possibly interfere with the subject’s participation in the
study.
19. Known ischemic heart disease or a history of myocardial infarction (MI) within the previous 12
months, coronary artery bypass surgery or percutaneous transluminal coronary angioplasty
(PTCA).
20. Presence of QT intervals >480 ms for men, >500ms for women, history of congenital long QT
syndromes, or risk of Torsades de Pointes because of family history of sudden death, etc.
21. Symptomatic hypotension or orthostatic hypotension which is defined as a decrease of 30
mmHg or more in systolic blood pressure (SBP) and/or a decrease of 20 mmHg or more in
diastolic blood pressure (DBP) after approximately one minute in upright position, compared to
the previous supine blood pressure or development of symptoms. The abnormal values should
be confirmed at two separate measurements.
22. A history of more than one episode of vasovagal syncope.
23. Uncorrected or uncontrolled hypothyro
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method