Reboxetine and Citalopram as an Adjunct Treatment to Second Generation Antipsychotics in the Treatment of Negative Symptoms of Schizophrenia
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|ClinicalTrials.gov Identifier: NCT01300364|
Recruitment Status : Unknown
Verified November 2008 by Fundació Sant Joan de Déu.
Recruitment status was: Recruiting
First Posted : February 21, 2011
Last Update Posted : February 21, 2011
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)
|Condition or disease||Intervention/treatment||Phase|
|Schizophrenia||Drug: Reboxetine Drug: citalopram (SSRI)||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||249 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||Double-blind Clinical Trial Controlled With Placebo of the Efficacy of Reboxetine and Citalopram as an Adjunct Treatment to Second Generation Antipsychotics in the Treatment of Negative Symptoms of Schizophrenia|
|Study Start Date :||November 2008|
|Estimated Primary Completion Date :||December 2011|
|Placebo Comparator: sugar pill||
8mg/day.Drug: citalopram (SSRI)
|Active Comparator: reboxetine (NRI)||
Drug: citalopram (SSRI)
|Active Comparator: citalopram (SSRI)||
- The primary efficacy end-point will be the change in the score of the PANSS negative subscale from baseline to follow-up assessment. [ Time Frame: 24 weeks ]
- 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. [ Time Frame: 24 weeks ]
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): NCT01300364
|Contact: Judith Usall U R, DRA.||936002650 ext firstname.lastname@example.org|
|Parc Sanitari Sant Joan de Déu||Recruiting|
|Sant Boi Llobregat, Barcelona, Spain|
|Contact: Judith Usall 93 6002650 ext 2356 email@example.com|