Add-on Dextromethorphan in Bipolar Disorders

NCT01188265 | Completed Phase 3 DMC

• 1 other identifier: HR-95-110
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

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.

Conditions

Bipolar Disorder

Outcome Measures

Primary Outcomes (2)

• Young's Mania Rating Scale (YMRS)

  The severity of current manic symptoms will be assessed by using the YMRS

  baseline, 1, 2, 4, 8 and 12 weeks

• Hamilton Depression Rating Scale (HDRS)

  The severity of depressive symptoms will be evaluated by HDRS

  baseline, 1, 2, 4, 8 and 12 weeks

Secondary Outcomes (2)

• blood samples

  baseline, 1, 2, 4, 8 and 12 weeks

• lipid profiles

  baseline, after treatment

Study Arms (3)

Valproate & dextromethorphan 30 mg

EXPERIMENTAL

Valproate and dextromethorphan 30 mg per day

Drug: Valproate; Drug: Dextromethorphan 30 mg

VPA & dextromethorphan 60 mg

EXPERIMENTAL

VPA \& dextromethorphan 60 mg per day

Drug: Valproate; Drug: Dextromethorphan 60 mg per day

VPA & Placebo

ACTIVE COMPARATOR

VPA \& placebo

Drug: Valproate; Drug: Placebo

Interventions

Valproate DRUG

VPA & Placebo; VPA & dextromethorphan 60 mg; Valproate & dextromethorphan 30 mg

Dextromethorphan 60 mg per day DRUG

VPA plus dextromethorphan 60 mg per day

VPA & dextromethorphan 60 mg

Placebo DRUG

VPA plus placebo

VPA & Placebo

Dextromethorphan 30 mg DRUG

VPA \& Dextromethorphan 30 mg per day

Valproate & dextromethorphan 30 mg

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 ≦65 years.
• A diagnosis of bipolar I or II disorder according to DSM-IV criteria made by a specialist in psychiatry.
• A total of HDRS score at least 18 or YMRS score at least 14 at screen.
• 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 judgment or not willing to comply with contraception for duration of study.
• Females who are pregnant or nursing.
• 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.
• Axis-I DSM-IV diagnosis other than bipolar I or II disorder.
• 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.
• History of intolerance to valproate 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 doubleblind medication.
• 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.
• Increase in total SGOT, SGPT, BUN and creatinine by more than 3X ULN (upper limit of normal).
• History of idiopathic or drug-induced agranulocytosis.
• 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.

Sponsors & Collaborators

• National Cheng-Kung University Hospital: lead
• National Health Research Institutes, Taiwan: collaborator
• TTY Biopharm: collaborator

Study Sites (1)

Ru-Band Lu

Tainan, 704, Taiwan

Location

MeSH Terms

Conditions

Bipolar Disorder

Interventions

Valproic Acid; Dextromethorphan

Condition Hierarchy (Ancestors)

Bipolar and Related Disorders; Mood Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Pentanoic Acids; Valerates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Fatty Acids, Volatile; Fatty Acids; Lipids; 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 3
• 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 25, 2010
• Study Start: June 1, 2007
• Primary Completion: December 1, 2010
• Study Completion: June 1, 2011
• Last Updated: September 17, 2013

Record last verified: 2013-09

Locations

TW (1)