Add-On Therapy to Risperidonein Schizophrenia

NCT01189006 | Completed Phase 2 DMC

• 2 other identifiers: DM-SchizoTaiwan NIH
• Study Type: interventional
• Target: 161
• Locations: 1 country
• Sites: 1

Brief Summary

These results suggest that the DA neuroprotection provided by DM in the inflammation-related neurodegenerative models is not mediated through the NMDA receptor.

Conditions

Schizophrenia

Outcome Measures

Primary Outcomes (7)

• positive and negative symptoms in schizophrenia

  baseline

• positive and negative symptoms in schizophrenia

  week1

• positive and negative symptoms in schizophrenia

  week2

• positive and negative symptoms in schizophrenia

  week4

• positive and negative symptoms in schizophrenia

  week6

• positive and negative symptoms in schizophrenia

  week8

• positive and negative symptoms in schizophrenia

  week11

Secondary Outcomes (3)

• Specific Serum Immunological Parameters

  baseline

• Specific Serum Immunological Parameters

  week11

• lipid profiles

  based line, after treatment

Study Arms (1)

dextromethorphan

EXPERIMENTAL

Research clinical trial of double-blind, stratified randomized, parallel group, double-centre study

Drug: Dextromethorphan

Interventions

Dextromethorphan DRUG

Add-On double-blind study treatment commenced at randomization for 11 weeks while patients were continuing open-label risperidone. Randomization was immediately preceded by a one week open-label Risperidone-Only Treatment period. Patients who were receiving antipsychotics medication(s) at screen other than risperidone alone was withdrawn from previous non-risperidone medication(s) and at the same time commenced risperidone in titrating doses over a week. This Antipsychotic Switch-Over Period occurred between Screen and Risperidone-Only Treatment period. Patients remained hospitalized for at least during the Risperidone-Only treatment Period and first week of Add-On treatment Period.

dextromethorphan

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female patient aged ≧18 and ≦60 years.
• A diagnosis of schizophrenia or schizoaffective disorder according to DSM-IV criteria made by a specialist in psychiatry.
• Acute exacerbation of schizophrenia.
• A total of PANSS score of at least 60 at screen.
• History of schizophrenia ≦ 15 years (from onset of prodromal symptoms).
• Signed informed consent by patient or legal representative
• Patient or a reliable caregiver can be expected to ensure acceptable compliance and visit attendance for the duration of the study.

You may not qualify if:

• Women of childbearing potential not using adequate contraception as per investigator judgement or not willing to comply with contraception for duration of study.
• Less than a full cycle has lapsed at time of screening following the last injection of a depot antipsychotic
• Females who are pregnant or nursing.
• Patient has received dextromethorphan, or other selective cyclo- oxygenase 2 inhibitors, or other anti-inflammatory medication within 1 week prior to first dose of double-blind medication.
• Axis-I DSM-IV diagnosis other than schizophrenia or schizoaffective disorder.
• Current evidence of an uncontrolled and/or clinically significant medical condition, e.g., cardiac, hepatic and renal failure that in the judgement of the investigator, would compromise patient safety or preclude study participation.
• History of intolerance to risperidone or dextromethorphan or other Cox-2 inhibitors.
• History of sensitivity reaction (e.g., urticaria, angioedema, bronchospasm, severe rhinitis, anaphylactic shock) precipitated by dextromethorphan.
• Patient has received electroconvulsive therapy (ECT) within 4 weeks prior to first dose of double-blind medication.
• Diagnosis of or treatment for oesophageal, gastric, pyloric channel, or duodenal ulceration or related complications (bleeding and/or perforation) within 30 days prior to receiving first dose of double-blind medication.
• Increase in total SGOT, SGPT, gamma-GT, BUN and creatinine by more than 3X ULN (upper limit of normal).
• History of idiopathic or drug-induced agranulocytosis.
• Alcohol, illegal or other substance-abuse within 6 months prior to study start, as defined by DSM-IV criteria.

Sponsors & Collaborators

• National Cheng-Kung University Hospital: lead

Study Sites (1)

Ru-Band Lu

Tainan, 704, Taiwan

Location

Related Publications (1)

• Chen SL, Lee SY, Chang YH, Chen SH, Chu CH, Tzeng NS, Lee IH, Chen PS, Yeh TL, Huang SY, Yang YK, Lu RB, Hong JS. Inflammation in patients with schizophrenia: the therapeutic benefits of risperidone plus add-on dextromethorphan. J Neuroimmune Pharmacol. 2012 Sep;7(3):656-64. doi: 10.1007/s11481-012-9382-z. Epub 2012 Jun 23.

  PMID: 22730040 DERIVED

MeSH Terms

Conditions

Schizophrenia

Interventions

Dextromethorphan

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds

Study Officials

• Ru-Band Lu, MD

  National Cheng-Kung University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 23, 2010
• First Posted: August 26, 2010
• Study Start: January 1, 2005
• Primary Completion: December 1, 2008
• Study Completion: December 1, 2008
• Last Updated: February 28, 2013

Record last verified: 2010-08

Locations

TW (1)