Add-on Dextromethorphan in Bipolar Disorders

Phase 3

Completed

• Conditions: Bipolar Disorder
• Interventions: Drug: Valproate; Drug: Dextromethorphan 30 mg; Drug: Dextromethorphan 60 mg per day; Drug: Placebo

• Registration Number: NCT01188265
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-06
• Study First Submitted: 2010-08-23
• Study First Submitted QC: 2010-08-23
• Study First Posted: 2010-08-25
• Primary Completion: 2010-12
• Study Completion: 2011-06
• Status Verified: 2013-09
• Last Update Submitted: 2013-09-16
• Last Update Posted: 2013-09-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 300

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Valproate & dextromethorphan 30 mg	Dextromethorphan 30 mg	Valproate and dextromethorphan 30 mg per day
VPA & dextromethorphan 60 mg	Dextromethorphan 60 mg per day	VPA \& dextromethorphan 60 mg per day
VPA & Placebo	Placebo	VPA \& placebo
Valproate & dextromethorphan 30 mg	Valproate	Valproate and dextromethorphan 30 mg per day
VPA & dextromethorphan 60 mg	Valproate	VPA \& dextromethorphan 60 mg per day
VPA & Placebo	Valproate	VPA \& placebo

Primary Outcome Measures

Name	Time	Method
Hamilton Depression Rating Scale (HDRS)	baseline, 1, 2, 4, 8 and 12 weeks	The severity of depressive symptoms will be evaluated by HDRS
Young's Mania Rating Scale (YMRS)	baseline, 1, 2, 4, 8 and 12 weeks	The severity of current manic symptoms will be assessed by using the YMRS

Secondary Outcome Measures

Name	Time	Method
blood samples	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	baseline, after treatment

Trial Locations

Locations (1)

Ru-Band Lu; 🇨🇳 Tainan, Taiwan