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Add-on Dextromethorphan in Bipolar Disorders (DM)

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ClinicalTrials.gov Identifier: NCT01188265
Recruitment Status : Completed
First Posted : August 25, 2010
Last Update Posted : September 17, 2013
Sponsor:
Collaborators:
National Health Research Institutes, Taiwan
TTY Biopharm
Information provided by (Responsible Party):
National Cheng-Kung University Hospital

August 23, 2010
August 25, 2010
September 17, 2013
June 2007
December 2010   (Final data collection date for primary outcome measure)
  • Young's Mania Rating Scale (YMRS) [ Time Frame: baseline, 1, 2, 4, 8 and 12 weeks ]
    The severity of current manic symptoms will be assessed by using the YMRS
  • Hamilton Depression Rating Scale (HDRS) [ Time Frame: baseline, 1, 2, 4, 8 and 12 weeks ]
    The severity of depressive symptoms will be evaluated by HDRS
Same as current
Complete list of historical versions of study NCT01188265 on ClinicalTrials.gov Archive Site
  • blood samples [ Time Frame: baseline, 1, 2, 4, 8 and 12 weeks ]
    The immune markers, cytokines will be measured at each time point to follow each patient's changes.
  • lipid profiles [ Time Frame: baseline, after treatment ]
blood samples [ Time Frame: baseline, 1, 2, 4, 8 and 12 weeks ]
The immune markers, cytokines will be measured at each time point to follow each patient's changes.
Not Provided
Not Provided
 
Add-on Dextromethorphan in Bipolar Disorders
Dextromethorphan Enhances the Therapeutic Efficacy of Valoproate in Bipolar Disorder Patients
Dextromethorphan has been reported affording neuroprotection on dopaminergic neurons and having protective effect against inflammation-related neuron damage. These anti-inflammatory and neuroprotective effects of dextromethorphan would suggest potential clinical benefits of dextromethorphan add-on therapy to valproate for bipolar disorder patients. This hypothesis was based on the findings that the mood stabilizers have been reported to be neuroprotective through the release of neurotrophic factors such as GDNF from astroglia. Thus, the combination treatment of mood stabilizers and dextromethorphan might improve the therapeutic efficacy for bipolar disorder patients.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Bipolar Disorder
  • Drug: Valproate
  • Drug: Dextromethorphan 60 mg per day
    VPA plus dextromethorphan 60 mg per day
  • Drug: Placebo
    VPA plus placebo
  • Drug: Dextromethorphan 30 mg
    VPA & Dextromethorphan 30 mg per day
  • Experimental: Valproate & dextromethorphan 30 mg
    Valproate and dextromethorphan 30 mg per day
    Interventions:
    • Drug: Valproate
    • Drug: Dextromethorphan 30 mg
  • Experimental: VPA & dextromethorphan 60 mg
    VPA & dextromethorphan 60 mg per day
    Interventions:
    • Drug: Valproate
    • Drug: Dextromethorphan 60 mg per day
  • Active Comparator: VPA & Placebo
    VPA & placebo
    Interventions:
    • Drug: Valproate
    • Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
300
Same as current
June 2011
December 2010   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  1. Male or female patient aged ≧18 and ≦65 years.
  2. A diagnosis of bipolar I or II disorder according to DSM-IV criteria made by a specialist in psychiatry.
  3. A total of HDRS score at least 18 or YMRS score at least 14 at screen.
  4. Signed informed consent by patient or legal representative
  5. Patient or a reliable caregiver can be expected to ensure acceptable compliance and visit attendance for the duration of the study.

Exclusion Criteria:

  1. Women of childbearing potential not using adequate contraception as per investigator judgment or not willing to comply with contraception for duration of study.
  2. Females who are pregnant or nursing.
  3. Patient has received dextromethorphan, or other selective cyclo- oxygenase 2 (Cox-2) inhibitors, or other anti-inflammatory medication within 1 week prior to first dose of double-blind medication.
  4. Axis-I DSM-IV diagnosis other than bipolar I or II disorder.
  5. Current evidence of an uncontrolled and/or clinically significant medical condition (e.g., cardiac, hepatic and renal failure), which in the judgments of the investigator, would compromise patient safety or preclude study participation.
  6. History of intolerance to valproate or dextromethorphan or other Cox-2 inhibitors.
  7. History of sensitivity reaction (e.g., urticaria, angioedema, bronchospasm, severe rhinitis, anaphylactic shock) precipitated by dextromethorphan.
  8. Patient has received electroconvulsive therapy (ECT) within 4 weeks prior to first dose of doubleblind medication.
  9. Diagnosis of or treatment for esophageal, 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.
  10. Inclusion in another bipolar disorder study or study for another indication with psychotropic's within the last 30 days prior to start of study.
  11. Increase in total SGOT, SGPT, BUN and creatinine by more than 3X ULN (upper limit of normal).
  12. History of idiopathic or drug-induced agranulocytosis.
  13. Substance-related disorders within 6 months prior to study start, borderline personality disorder, schizophrenia, or other major psychiatric disorders as defined by DSM-IV criteria.
Sexes Eligible for Study: All
18 Years to 65 Years   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
Taiwan
 
 
NCT01188265
HR-95-110
Yes
Not Provided
Not Provided
National Cheng-Kung University Hospital
National Cheng-Kung University Hospital
  • National Health Research Institutes, Taiwan
  • TTY Biopharm
Principal Investigator: Ru-Band Lu, MD National Cheng-Kung University Hospital
National Cheng-Kung University Hospital
September 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP