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| Name | Class |
|---|---|
| Centro de Investigación Biomédica en Red de Salud Mental | NETWORK |
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Main objective: To assess the efficacy of two antidepressants of different pharmacological families: citalopram (Selective serotonin reuptake inhibitors, SSRI) and reboxetine (Norepinephrine Reuptake inhibitor, NRI) as adjunct treatments to risperidone and olanzapine for the treatment of negative symptoms of schizophrenia.
Secondary objectives: To assess the efficacy of citalopram and reboxetine as adjunct treatments to risperidone and olanzapine for the treatment of cognitive symptoms of schizophrenia. To compare the efficacy of reboxetine and citalopram as adjunct treatments for the treatment of negative and cognitive symptoms of schizophrenia.
Method: Multicentric, randomized double-blind clinical trial compared to placebo with a six months follow-up. A total of 249 patients with a diagnosis of schizophrenia (DSM-IV criteria) and significant negative symptoms, will be recruited in the 9 participating centres. Variables: sociodemographic and clinical variables (PANSS, SANS, CGI global, GAF,LSP, Hamilton scale, BACS)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| sugar pill | Placebo Comparator |
| |
| reboxetine (NRI) | Active Comparator |
| |
| citalopram (SSRI) | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Reboxetine | Drug | 8mg/day. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| The primary efficacy end-point will be the change in the score of the PANSS negative subscale from baseline to follow-up assessment. | 24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Secondary efficacy endpoints will be the change in the scores of the total PANSS and all the other clinical, social and neuropsychological scales from baseline to follow-up evaluation. | 24 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Judith Usall U R, DRA. | Contact | 936002650 | 2356 | jusall@pssjd.org |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Parc Sanitari Sant Joan de Déu | Recruiting | Sant Boi Llobregat | Barcelona | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25004184 | Derived | Usall J, Lopez-Carrilero R, Iniesta R, Roca M, Caballero M, Rodriguez-Jimenez R, Oliveira C, Bernardo M, Corripio I, Sindreu SD, Gonzalez Piqueras JC, Felipe AE, Fernandez de Corres B, Ibanez A, Huerta R; Abordaje Sintomas Negativos Esquizofrenia Group. Double-blind, placebo-controlled study of the efficacy of reboxetine and citalopram as adjuncts to atypical antipsychotics for negative symptoms of schizophrenia. J Clin Psychiatry. 2014 Jun;75(6):608-15. doi: 10.4088/JCP.13m08551. |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Nov 2, 2012 | |
| Unrelease | Yes | |
| Release | Nov 15, 2012 | |
| Unrelease | Yes | |
| Release | Nov 19, 2012 | |
| Reset | Dec 17, 2012 | |
| Release | Apr 17, 2013 | |
| Reset | May 23, 2013 | |
| Release | May 27, 2013 | |
| Unrelease | Yes | |
| Release | May 29, 2013 | |
| Reset | Jul 3, 2013 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Nov 2, 2012 | Yes | |||
| Nov 15, 2012 |
| ID | Term |
|---|---|
| D012559 | Schizophrenia |
| ID | Term |
|---|---|
| D019967 | Schizophrenia Spectrum and Other Psychotic Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D000077593 | Reboxetine |
| D015283 | Citalopram |
| D017367 | Selective Serotonin Reuptake Inhibitors |
| ID | Term |
|---|---|
| D009025 | Morpholines |
| D010078 | Oxazines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| citalopram (SSRI) |
| Drug |
30mg/day |
|
| Yes |
| Nov 19, 2012 | Dec 17, 2012 |
| Apr 17, 2013 | May 23, 2013 |
| May 27, 2013 | Yes |
| May 29, 2013 | Jul 3, 2013 |
| D011437 |
| Propylamines |
| D000588 | Amines |
| D009930 | Organic Chemicals |
| D009570 | Nitriles |
| D001572 | Benzofurans |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D014179 | Neurotransmitter Uptake Inhibitors |
| D049990 | Membrane Transport Modulators |
| D045504 | Molecular Mechanisms of Pharmacological Action |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D018377 | Neurotransmitter Agents |
| D018490 | Serotonin Agents |
| D045505 | Physiological Effects of Drugs |