Reboxetine and Citalopram as an Adjunct Treatment to Second Generation Antipsychotics in the Treatment of Negative Symptoms of Schizophrenia
Primary Purpose
Schizophrenia
Status
Unknown status
Phase
Phase 4
Locations
Spain
Study Type
Interventional
Intervention
Reboxetine
citalopram (SSRI)
Sponsored by
About this trial
This is an interventional treatment trial for Schizophrenia
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.
Sites / Locations
- Parc Sanitari Sant Joan de DéuRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Placebo Comparator
Active Comparator
Active Comparator
Arm Label
sugar pill
reboxetine (NRI)
citalopram (SSRI)
Arm Description
Outcomes
Primary Outcome Measures
The primary efficacy end-point will be the change in the score of the PANSS negative subscale from baseline to follow-up assessment.
Secondary Outcome Measures
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.
Full Information
NCT ID
NCT01300364
First Posted
February 18, 2011
Last Updated
February 18, 2011
Sponsor
Fundació Sant Joan de Déu
Collaborators
Centro de Investigación Biomédica en Red de Salud Mental
1. Study Identification
Unique Protocol Identification Number
NCT01300364
Brief Title
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
2. Study Status
Record Verification Date
November 2008
Overall Recruitment Status
Unknown status
Study Start Date
November 2008 (undefined)
Primary Completion Date
December 2011 (Anticipated)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Fundació Sant Joan de Déu
Collaborators
Centro de Investigación Biomédica en Red de Salud Mental
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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)
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
249 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
sugar pill
Arm Type
Placebo Comparator
Arm Title
reboxetine (NRI)
Arm Type
Active Comparator
Arm Title
citalopram (SSRI)
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Reboxetine
Intervention Description
8mg/day.
Intervention Type
Drug
Intervention Name(s)
citalopram (SSRI)
Intervention Description
30mg/day
Primary Outcome Measure Information:
Title
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 Outcome Measure Information:
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Judith Usall U R, DRA.
Phone
936002650
Ext
2356
Email
jusall@pssjd.org
Facility Information:
Facility Name
Parc Sanitari Sant Joan de Déu
City
Sant Boi Llobregat
State/Province
Barcelona
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Judith Usall
Phone
93 6002650
Ext
2356
Email
jusall@pssjd.org
12. IPD Sharing Statement
Citations:
PubMed Identifier
25004184
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.
Results Reference
derived
Learn more about this trial
Reboxetine and Citalopram as an Adjunct Treatment to Second Generation Antipsychotics in the Treatment of Negative Symptoms of Schizophrenia
We'll reach out to this number within 24 hrs