A randomised, double-blind, parallel-group, active-controlled, flexible dose study exploring the efficacy and safety of 12 weeks treatment with Lu 31-130 in patients with schizophrenia - N/A
- Conditions
- MedDRA version: 9.1Level: PTClassification code 10052792Term: Schizophrenia, undifferentiated typeMedDRA version: 9.1Level: PTClassification code 10039638Term: Schizophrenia, disorganised typeu 31-130 is under development by H. Lundbeck A/S as an antipsychotic in the treatment of schizophreniaMedDRA version: 9.1Level: PTClassification code 10039639Term: Schizophrenia, paranoid typeMedDRA version: 9.1Level: PTClassification code 10039637Term: Schizophrenia, catatonic type
- Registration Number
- EUCTR2008-000479-11-CZ
- Lead Sponsor
- H. Lundbeck A/S
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 90
1. The patient and/or legally acceptable representative and/or impartial witness (if wished for by the patient) is/are able to read and understand the Patient Information Sheet
2. The patient and/or legally accepted representative and/or impartial witness (if wished for by the patient) has/have read the Patient Information Sheet
3. The patient and/or legally accepted representative has/have signed the Informed Consent Form and impartial witness (if wished for by the patient) has co-signed the Informed Consent Form (if relevant) and this was done prior to the conduct of any study related procedures
4. The patient has a primary diagnosis of schizophrenia according to DSM-IV TR (codes 295.10, 295.20, 295.30, 295.90)
5. The patient is a man or woman, aged between 18 and 65 years (extremes included)
6. The patient is able to communicate with study personnel
7. The patient has a PANSS total score between 70 and 120 (extremes included) at Screening 2 and Baseline
8. The patient has a CGI-S score equal or more than 4 (moderately ill) at Screening 1, Screening 2 and Baseline
9. The patient is willing to be hospitalised during the period from Screening 2 until vist 5 at least
10. The patient, if a woman, must:
- agree not to try to become pregnant during the study, AND
- use adequate contraception (adequate contraception is defined as oral/systemic contraception, intrauterine device, diaphragm in combination with spermicide, or condom for male partner in combination with spermicide), OR
- have been surgically sterilised prior to Baseline, OR
- have had a hysterectomy prior to Baseline, OR
- not have been sexually active
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
1 The patient has a current Axis I primary psychiatric diagnosis other than schizophrenia except for nicotine- or caffeine-related disorder (DSM-IV TR criteria)
2 The patient is at significant risk of suicide
3 The patient has shown violent behaviour within 12 months prior to Screening1
4 The patient is treatment-resistent to antipsychotic treatment
5 The patient has been treated with clozapine within 60 days prior to Screening1
6 The patient has other psychiatric, neurological (including tardive dyskinesia), or behavioural disorders that may interfere with the study results
7 The patient has a history of alcohol- or substance-related disorder (except nicotine, caffeine) based on DSM-IV-TR criteria within six months prior to Screening 1
8 The patient has a positive drug screen at Screening1, with the exception that positive result for opioids, cannabinoids, and benzodiazepines will be evaluated by Investigator on the impact for study participation
9 The patient has abnormal (above the upper limit of normal range) liver biochemistry
values (that is, ASAT, ALAT, AP, and total bilirubin) based on the blood samples drawn at Screening1.
10 The patient has positive serology for Hepatitis A (anti HAV IgM), Hepatitis B (HbsAg), Hepatitis C (HCV), or HIV based on blood samples drawn at Screening 1
11 The patient has a present condition that might compromise the liver function (for example alcohol abuse, hepatitis, hepatic insufficiency, cholestasis, haemochromatosis, deficit in alpha 1 antitrypsine, Wilson Disease, autoimmune diseases, cirrhosis)
12 The patient has one or more laboratory values outside the normal reference range, that are considered by investigator to be clinically significant
13 The patient is diagnosed with diabetes mellitus
14 The patient has 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
15 The patient has a history of neuroleptic malignant syndrome
16 The patient has an uncorrected hypothyroridism or hyperthyroidism
17 The patient has a history of severe drug allergy or hypersensitivity, to or has other contraindications to serotonergic agents, dopamine antagonists, or dopamine agonists
18 The patient uses disallowed medication, or it is expected that the patient will require treatment with at least one of the disallowed concomittant medications during the study
19 The patient has a clinically significant unstable illness
20 The patient has a 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 Screening1
21 The patient has clinically significant abnormal vital signs
22 The patient has uncontrolled or symptomatic hypotension, or orthostatic hypotension
23 The patient has a history of repeated vasovagal syncope
24 The patient has an abnormal ECG recorded at Screening1 that is considered to be clinically significant
25 The patient has a QTc interval on the ECG recorded at Screening1 above 450 msec when using the Fridericia correction or a family history of Long QT Syndrome or a history of hypokalaemia or has known heart failure (NYHA II-IV) or if the patient takes medication that prolongs the QTc interval
26 The patient has a known ischaemic heart disease or a history of myocardial infarction (within the previous 12 months), coronary artery bypass surgery or percutaneo
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