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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
Sponsor:
Collaborator:
Centro de Investigación Biomédica en Red de Salud Mental
Information provided by:
Fundació Sant Joan de Déu

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)


Condition or disease Intervention/treatment Phase
Schizophrenia Drug: Reboxetine Drug: citalopram (SSRI) Phase 4

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 249 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Schizophrenia

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.




Primary Outcome Measures :
  1. 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 Measures :
  1. 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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

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


Contacts
Contact: Judith Usall U R, DRA. 936002650 ext 2356 jusall@pssjd.org

Locations
Spain
Parc Sanitari Sant Joan de Déu Recruiting
Sant Boi Llobregat, Barcelona, Spain
Contact: Judith Usall    93 6002650 ext 2356    jusall@pssjd.org   
Sponsors and Collaborators
Fundació Sant Joan de Déu
Centro de Investigación Biomédica en Red de Salud Mental

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Judith Usall Rodié, Parc Sanitari Sant Joan de Déu
ClinicalTrials.gov Identifier: NCT01300364     History of Changes
Other Study ID Numbers: EC07/90093
First Posted: February 21, 2011    Key Record Dates
Last Update Posted: February 21, 2011
Last Verified: November 2008

Additional relevant MeSH terms:
Schizophrenia
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Antipsychotic Agents
Citalopram
Reboxetine
Dexetimide
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Psychotropic Drugs
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Serotonin Agents
Antidepressive Agents, Second-Generation
Antidepressive Agents
Antiparkinson Agents
Anti-Dyskinesia Agents
Parasympatholytics
Autonomic Agents
Peripheral Nervous System Agents
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents
Adrenergic Uptake Inhibitors
Adrenergic Agents