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
  Purpose

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 Intervention Phase
Schizophrenia
Drug: Reboxetine
Drug: citalopram (SSRI)
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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

Resource links provided by NLM:


Further study details as provided by Fundació Sant Joan de Déu:

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. [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]

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. [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 249
Study Start Date: November 2008
Estimated Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided by Fundació Sant Joan de Déu

Additional 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
Study First Received: February 18, 2011
Last Updated: February 18, 2011
Health Authority: Spain: Spanish Agency of Medicines
United States: Food and Drug Administration

Additional relevant MeSH terms:
Schizophrenia
Schizophrenia and Disorders with Psychotic Features
Mental Disorders
Antipsychotic Agents
Citalopram
Reboxetine
Dexetimide
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Psychotropic Drugs
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
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

ClinicalTrials.gov processed this record on September 18, 2014