Clinical trial NCT01300364: Reboxetine and Citalopram as an Adjunct Treatment to Second Generation Antipsychotics in the Treatment of Negative Symptoms of Schizophrenia
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 type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Schizophrenia
Lead sponsor: Fundació Sant Joan de Déu
Sponsor class: OTHER
Collaborators: name: Centro de Investigación Biomédica en Red de Salud Mental
First posted: 2011-02-21
Enrollment: 249
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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)


Eligibility criteria: Inclusion Criteria:

* Diagnosis of schizophrenia (DSM-IV criteria)
* Stable doses of antipsychotic medication (olanzapine, risperidone)for at least 60 days prior to study initiation
* Presence of significant negative symptoms (defined as one or more negative symptom score grater than 4 in the PANSS scale) (Kay 1987)
* Patients have to give written informed consent to participate in the study

Exclusion Criteria:

* Patients with a substance abuse/dependence diagnosis in the previous six months.
* Mental Retardation.
* Patients taking antidepressant in the last 4 months before the trial.
* Patients taking other antipsychotic medication, except: sinquan 100, Entumine 40, Largactil 100 and Seroquel 200.
* Patients who score more than 20 in Hamilton Rating Scale for Depression.
* Pregnancy or lactation.
* Serious impaired kidney function.
* History of hemorrhagic disorders.
* Reboxetine or citalopram allergy.

Primary outcomes:
measure: The primary efficacy end-point will be the change in the score of the PANSS negative subscale from baseline to follow-up assessment.
timeFrame: 24 weeks
Secondary outcomes:
measure: 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.
timeFrame: 24 weeks
Other outcomes:
Locations:
city: Sant Boi Llobregat
country: Spain
facility: Parc Sanitari Sant Joan de Déu
state: Barcelona
Study officials:
References:
citation: 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.