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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

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Bipolar Disorder Drug: Valproate Drug: Dextromethorphan 60 mg per day Drug: Placebo Drug: Dextromethorphan 30 mg Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Dextromethorphan Enhances the Therapeutic Efficacy of Valoproate in Bipolar Disorder Patients
Study Start Date : June 2007
Actual Primary Completion Date : December 2010
Actual Study Completion Date : June 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bipolar Disorder

Arm Intervention/treatment
Experimental: Valproate & dextromethorphan 30 mg
Valproate and dextromethorphan 30 mg per day
Drug: Valproate
Drug: Dextromethorphan 30 mg
VPA & Dextromethorphan 30 mg per day

Experimental: VPA & dextromethorphan 60 mg
VPA & dextromethorphan 60 mg per day
Drug: Valproate
Drug: Dextromethorphan 60 mg per day
VPA plus dextromethorphan 60 mg per day

Active Comparator: VPA & Placebo
VPA & placebo
Drug: Valproate
Drug: Placebo
VPA plus placebo




Primary Outcome Measures :
  1. 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

  2. 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


Secondary Outcome Measures :
  1. 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.

  2. lipid profiles [ Time Frame: baseline, after treatment ]


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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:

  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.

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): NCT01188265


Locations
Taiwan
Ru-Band Lu
Tainan, Taiwan, 704
Sponsors and Collaborators
National Cheng-Kung University Hospital
National Health Research Institutes, Taiwan
TTY Biopharm
Investigators
Principal Investigator: Ru-Band Lu, MD National Cheng-Kung University Hospital

Responsible Party: National Cheng-Kung University Hospital
ClinicalTrials.gov Identifier: NCT01188265     History of Changes
Other Study ID Numbers: HR-95-110
First Posted: August 25, 2010    Key Record Dates
Last Update Posted: September 17, 2013
Last Verified: September 2013

Additional relevant MeSH terms:
Disease
Bipolar Disorder
Pathologic Processes
Bipolar and Related Disorders
Mental Disorders
Dextromethorphan
Valproic Acid
Antitussive Agents
Respiratory System Agents
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Anticonvulsants
Enzyme Inhibitors
GABA Agents
Antimanic Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs