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)

Study Overview

• Status: Unknown
• Conditions: Schizophrenia
• Intervention / Treatment: Drug: Reboxetine; Drug: citalopram (SSRI)

• Study Type: Interventional
• Enrollment (Anticipated): 249
• Phase: Phase 4

Contacts and Locations

Study Locations

• Spain
  • Barcelona
    • Sant Boi Llobregat, Barcelona, Spain
      • Recruiting
      • Parc Sanitari Sant Joan de Déu
      • Contact: Judith Usall; Phone Number: 2356 93 6002650; Email: jusall@pssjd.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 63 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: sugar pill	Drug: Reboxetine; 8mg/day.; Drug: citalopram (SSRI); 30mg/day
Active Comparator: reboxetine (NRI)	Drug: citalopram (SSRI); 30mg/day
Active Comparator: citalopram (SSRI)	Drug: Reboxetine; 8mg/day.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Fundació Sant Joan de Déu
• Collaborators: Centro de Investigación Biomédica en Red de Salud Mental

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: November 1, 2008
• Primary Completion (Anticipated): December 1, 2011

Study Registration Dates

• First Submitted: February 18, 2011
• First Submitted That Met QC Criteria: February 18, 2011
• First Posted (Estimate): February 21, 2011

Study Record Updates

• Last Update Posted (Estimate): February 21, 2011
• Last Update Submitted That Met QC Criteria: February 18, 2011
• Last Verified: November 1, 2008

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Schizophrenia Spectrum and Other Psychotic Disorders; Schizophrenia; Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Psychotropic Drugs; Serotonin Uptake Inhibitors; Neurotransmitter Uptake Inhibitors; Membrane Transport Modulators; Serotonin Agents; Antidepressive Agents; Antidepressive Agents, Second-Generation; Adrenergic Uptake Inhibitors; Citalopram; Reboxetine
• Other Study ID Numbers: EC07/90093