None listed
Conditions
Interventions
Group 1 Type of group
Bifeprunox 20 mg / day, encapsulated tablets, orally during the double-blind period of 12 weeks. Then Bifeprunox 20 mg / day, tablets encapsulated by the second double-blind period for 9 months.
Group name:Group 3 Type of group
Placebo orally during the double-blind period of 12 weeks. Then Bifeprunox 20 mg / day, encapsulated tablets, orally for the second double-blind period for 9 months.
Sponsors
H. LUNDBECK A/S,
Eligibility
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: • The subject and / or a legal representative and / or an impartial witness are trained to read and understand the Subject Information Sheet. • The subject and / or a legal representative and / or an impartial witness have read the Informed Consent Form. • The subject and / or a legal representative have signed the Informed Consent Form and the impartial witness has jointly signed the Informed Consent Form, if applicable. • The subject is a man or woman between 18 and 65 years of age (ends included). • The subject is able to communicate with the study staff. • The subject has a primary diagnosis of schizophrenia according to the current Diagnostic and Statistical Manual of Mental Disorders, 4th Edition, Revised Text (DSM-IV-TR: codes 295.10, 295.20, 295.30, 295.60, 295.90). • The subject has a score in CGI-S> 4 (moderately ill) in the selection and in the baseline. • The subject has a total score in the PANSS> 60 in the selection and in the baseline. • The subject is an inpatient, partially hospitalized or outpatient of whom the center can document at least monthly contacts (personal or telephone) for a minimum of 3 months prior to the selection. • The antipsychotic treatment of the subject was maintained in the following manner: - In the selection: the antipsychotic (s) have remained the same within the 8 weeks prior to the selection. - In the baseline: the antipsychotic (s) have not been modified (agent / s and doses between the selection and the baseline). • The subject is in the maintenance phase and has not had acute outbreaks according to the investigator´s criteria. - In the selection: within 8 weeks prior to selection. - In the baseline: between the selection and the baseline (4 weeks). • In case of being a woman, the subject must: - Have had a pregnancy test with a negative result (reactive strip in the urine) in the baseline, - Commit not to get pregnant during the study, and - Use adequate contraceptive methods ( adequate contraception is defined as oral / systemic contraception, intrauterine device, diaphragm in combination with spermicide, or condom for the male partner in combination with spermicide), OR - having had their last menstrual period at least 24 months before the baseline, OR - Have been surgically sterilized before the baseline, OR - Have undergone a hysterectomy before the baseline, OR - Not be sexually active.
Exclusion criteria
Exclusion criteria: • Subject presents a current primary Axis I psychiatric diagnosis other than schizophrenia (DSM-IV-TR criteria). • The subject is at significant risk of suicide defined as: - Significant risk of suicide in the 12 months prior to selection according to the investigator´s criteria, and / or - A suicide attempt that endangers life within 3 months. years before the selection. • The subject showed violent behavior within the 12 months prior to the selection according to the investigator´s criteria. • The subject is resistant to antipsychotic treatment according to the investigator´s criteria. • The subject has been treated with clozapine within 60 days prior to the selection. • The subject has other psychiatric, neurological or behavioral disorders that may interfere with the conduct or interpretation of the results of the study. • The subject has a history of moderate or severe brain trauma or other neurological disorders and systemic diseases, which can probably affect the functioning of the central nervous system. • The subject has ischemic heart disease or a history of myocardial infarction (within the previous 12 months), coronary artery bypass surgery, or percutaneous transluminal coronary angioplasty. • The subject has a history of neuroleptic malignant syndrome. • Subject has hypothyroidism or uncorrected hyperthyroidism. • The subject has a current diagnosis or a history of substance abuse (except nicotine, caffeine) or alcohol, according to the DSM-IV-TR criteria, within 6 months prior to selection. • The subject presents a positive urine drug test in the selection with the exception that positive results for opioids, cannabinoids and benzodiazepines will be evaluated by the researcher and the Lundbeck medical expert regarding the potential impact on participation in the study. study. • The subject has a history of hypersensitivity or severe allergy to the drug, or known hypersensitivity or other contraindications to serotonergic agents, antagonists or dopamine agonists. • The subject has received antidepressants or mood stabilizers (specified in Appendix II) within the 2-month period prior to selection. • The subject uses non-permitted medications (specified in Appendix II) or it is anticipated that the subject will require treatment with at least one of the concomitant medications not allowed during the study. • The subject presents a clinically significant unstable disease; for example, hepatic or renal insufficiency, or a cardiovascular, pulmonary, gastrointestinal, endocrine, neurological, infectious, neoplastic, hematological, autoimmune or metabolic disease different from those that can originate from antipsychotic treatment. Hypertension and diabetes treated adequately are not considered an exclusion criterion. • The subject has a malignant disease or a history of malignant disease, other than treated in situ cervical carcinoma or basal skin cell carcinoma, within the last 5 years prior to selection. • The subject shows abnormal vital signs of clinical significance. • The subject has hypotension, or orthostatic hypotension without control or symptomatic, which is defined as a decrease of 30 mmHg or a greater amount in systolic blood pressure and / or a decrease of 20 mmHg or a greater amount in diastolic blood pressure after about 1 minute in a vertical position, compared to the previous blood pressure in the supine position or with the development
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:The Positive and Negative Syndromes Scale (PANSS) is a rating scale designed to measure the severity of psychopathology in adult patients with schizophrenia, schizoaffective disorders and other psychotic disorders. Emphasis is placed on positive and negative symptoms. The PANSS includes 3 scales and 30 items Measure:Variation of the total score of the PANSS. Timepoints:During the study | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:The Positive and Negative Syndromes Scale (PANSS) is a rating scale designed to measure the severity of psychopathology in adult patients with schizophrenia, schizoaffective disorders and other psychotic disorders. Emphasis is placed on positive and negative symptoms. The PANSS includes 3 scales and 30 items Measure:Variation in the score of the subscales with the general positive, negative and psychopathological symptoms of the PANSS Timepoints:During the study ; Outcome name:The CGI-S evaluates the researchers impression of the patients current mental state. The investigator should use his or her total clinical experience with this patient population and rate the current severity of the patients illness on a 7-point scale. The CGI-I evaluates the improvement (or worsening) of the patient. The investigator must evaluate the patients baseline condition on a 7-point scale. Measure:Changes in the scores of the CGI-S, the CGI-I and the CDSS Timepoints:During the study | — |
Countries
Bulgaria, Greece, Peru
Contacts
Public ContactGABRIELA CELINA LOYOLA
IQVIA RDS Peru S.R.L
Outcome results
None listed