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Reboxetine and Citalopram as an Adjunct Treatment to Second Generation Antipsychotics in the Treatment of Negative Symptoms of Schizophrenia

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2008 by Fundació Sant Joan de Déu.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Centro de Investigación Biomédica en Red de Salud Mental
Information provided by:
Fundació Sant Joan de Déu
ClinicalTrials.gov Identifier:
NCT01300364
First received: February 18, 2011
Last updated: NA
Last verified: November 2008
History: No changes posted

February 18, 2011
February 18, 2011
November 2008
December 2011   (final data collection date for primary outcome measure)
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 ] [ Designated as safety issue: No ]
Same as current
No Changes Posted
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 ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Reboxetine and Citalopram as an Adjunct Treatment to Second Generation Antipsychotics in the Treatment of Negative Symptoms of Schizophrenia
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

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)

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Schizophrenia
  • Drug: Reboxetine
    8mg/day.
  • Drug: citalopram (SSRI)
    30mg/day
  • Placebo Comparator: sugar pill
    Interventions:
    • Drug: Reboxetine
    • Drug: citalopram (SSRI)
  • Active Comparator: reboxetine (NRI)
    Intervention: Drug: citalopram (SSRI)
  • Active Comparator: citalopram (SSRI)
    Intervention: Drug: Reboxetine
Usall J, López-Carrilero R, Iniesta R, Roca M, Caballero M, Rodriguez-Jimenez R, Oliveira C, Bernardo M, Corripio I, Sindreu SD, González Piqueras JC, Felipe AE, Fernandez de Corres B, Ibáñez A, Huerta R; Abordaje Síntomas 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
249
Not Provided
December 2011   (final data collection date for primary outcome measure)

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.
Both
18 Years to 65 Years
No
Contact: Judith Usall U R, DRA. 936002650 ext 2356 jusall@pssjd.org
Spain
 
NCT01300364
EC07/90093
Yes
Judith Usall Rodié, Parc Sanitari Sant Joan de Déu
Fundació Sant Joan de Déu
Centro de Investigación Biomédica en Red de Salud Mental
Not Provided
Fundació Sant Joan de Déu
November 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP