Efficacy of Lu 31-130 in Patients With Schizophrenia
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT00770744 |
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Recruitment Status :
Completed
First Posted : October 10, 2008
Last Update Posted : November 8, 2016
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Schizophrenia | Drug: Zicronapine Drug: Olanzapine | Phase 2 |
Schizophrenia is a serious and disabling mental disorder that affects approximately 1% of the world's population. Antipsychotic drugs remain the cornerstone in the pharmacotherapy of schizophrenia. However, none of the available drugs is ideal, in particular because of their complex safety profile and the limited effectiveness against certain symptom domains. Whereas positive symptoms respond to treatment the effects on negative symptoms and cognitive impairment are only very modest.
Thus present treatment options leave room for improvement and call for new, more effective pharmacotherapies for the treatment of schizophrenia. In the current study, patients suffering from schizophrenia and experiencing clinically significant symptoms of the disease will be included. Eligible patients will be randomised to blinded treatment with either flexible doses of Lu 31-130 or flexible doses of a standard antipsychotic treatment (olanzapine) for 12 weeks. The efficacy (including potential effects on cognitive symptoms) and the safety of Lu 31-130 will be explored in comparison to olanzapine.
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 93 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Double (Participant, Investigator) |
| Primary Purpose: | Treatment |
| Official Title: | 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 |
| Study Start Date : | September 2008 |
| Actual Primary Completion Date : | October 2009 |
| Actual Study Completion Date : | November 2009 |
| Arm | Intervention/treatment |
|---|---|
| Experimental: Zicronapine |
Drug: Zicronapine
5-7mg/day; orally, encapsulated tablets, once daily
Other Name: Lu 31-130 |
| Active Comparator: Olanzapine |
Drug: Olanzapine
10-15mg/day; orally, encapsulated tablets, once daily
Other Name: Zyprexa |
- Change in the Positive and Negative Syndrome Scale (PANSS) score from Baseline to Week 12 [ Time Frame: 12 weeks ]
- Change in cognitive symptoms using Assessment of Cognition in Schizophrenia (BACS) test battery. Change in Clinical Global Impression/Improvement (CGI-S/I) scores. Change in Calgary Depression Scale for Schizophrenia (CDSS) score. Safety assessments. [ Time Frame: 12 weeks ]
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| Ages Eligible for Study: | 18 Years to 65 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- The subject has a primary diagnosis of schizophrenia
- The subject experiences clinically significant symptoms
- The subject is willing to be hospitalized during the initial period of the study
- The subject has normal serum values of parameters associated with liver function
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00770744
| Czech Republic | |
| CZ001 | |
| Ceske Budejovice, Czech Republic, 37087 | |
| CZ005 | |
| Litomerice, Czech Republic, 41201 | |
| CZ004 | |
| Lnare, Czech Republic, 38742 | |
| CZ002 | |
| Olomouc, Czech Republic, 77111 | |
| CZ003 | |
| Olomouc, Czech Republic, 77520 | |
| CZ006 | |
| Praha 8, Czech Republic, 18100 | |
| France | |
| FR001 | |
| Clermont-Ferrand, Cedex 1, France, 63003 | |
| FR002 | |
| Dole, France, 39100 | |
| FR003 | |
| Jonzac, France, 17503 | |
| Hong Kong | |
| HK001 | |
| Hong Kong, Hong Kong | |
| Indonesia | |
| ID001 | |
| Bangli, Indonesia, 80613 | |
| ID002 | |
| Jakarta, Indonesia, 10430 | |
| Philippines | |
| PH002 | |
| Baguio, Philippines, 2600 | |
| PH001 | |
| Mandaluyong City, Philippines, 1553 | |
| Poland | |
| PL003 | |
| Gdansk, Poland, 80-211 | |
| PL002 | |
| Lodz, Poland, 92-216 | |
| Spain | |
| ES001 | |
| Barcelona, Spain, 8025 | |
| ES002 | |
| Salamanca, Spain, 37003 | |
| ES004 | |
| Zamora, Spain, 49021 | |
| Thailand | |
| TH001 | |
| Bangkok, Thailand, 10330 | |
| TH002 | |
| Chiang Mai, Thailand, 50200 | |
| Study Director: | Email contact via H. Lundbeck A/S | LundbeckClinicalTrials@lundbeck.com |
Study Data/Documents: EMA EudraCT Results
| Responsible Party: | H. Lundbeck A/S |
| ClinicalTrials.gov Identifier: | NCT00770744 History of Changes |
| Other Study ID Numbers: |
12396A 2008-000479-11 ( EudraCT Number ) |
| First Posted: | October 10, 2008 Key Record Dates |
| Last Update Posted: | November 8, 2016 |
| Last Verified: | November 2016 |
Keywords provided by H. Lundbeck A/S:
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Schizophrenia Antipsychotic Olanzapine Lu 31-130 |
Additional relevant MeSH terms:
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Schizophrenia Schizophrenia Spectrum and Other Psychotic Disorders Mental Disorders Olanzapine Antiemetics Autonomic Agents Peripheral Nervous System Agents Physiological Effects of Drugs Gastrointestinal Agents Antipsychotic Agents |
Tranquilizing Agents Central Nervous System Depressants Psychotropic Drugs Serotonin Uptake Inhibitors Neurotransmitter Uptake Inhibitors Membrane Transport Modulators Molecular Mechanisms of Pharmacological Action Neurotransmitter Agents Serotonin Agents |