Combination of Dextromethorphan and Memantine in Treating Bipolar Disorder

NCT03039842 | Unknown Phase 3 DMC

• 1 other identifier: CombindBP2014
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

Brief Summary

This is a research clinical trial of double-blind, stratified randomized, parallel group, two-centre study. It will be conducted in a total of 250\~300 male and female subjects from the Department of Psychiatry at National Cheng Kung University Hospital. Eligible subjects will be psychiatric out- and in-patients, aged between 18\~65 years old, who have psychiatric evaluation with clinically suspected of having bipolar II disorder and fulfill the inclusion and exclusion criteria. The add-on double-blind study treatment with dextromethorphan/place will commence at randomization for while patients continue open-label valproate. Subjects will be enrolled for 12 weeks double-blind add-on treatment and randomly assigned to (1) 30mg dextromethorphan+valproate, (2) 5mg memantine+valproate, (3) dextromethorphan+memantine+valproate or (4) placebo+valproate. Concomitant benzodiazepine medication (preferably up to 8mg lorazepam) may be used for daytime sedation, agitation or insomnia during the study. For the consideration of the less influence to immune-system, resperidone 1-3mg/daily and fluoxetine maximum 20mg/daily will be chose. We will measure the treatment response and side effect to clarify the curative effect of DM and memantine add-on therapy to valproate in the treatment of bipolar disorders. This study is being performed to investigate the possibly significant beneficial effects on the subtypes of bipolar disorders psychopathology.

Conditions

Bipolar Disorder II

Keywords

dextromethorphan; memantine; treatment response

Outcome Measures

Primary Outcomes (1)

• treatment change assessed by plasma levels of cytokines (e.g., IL-6, IL-8)

  change assessment

  baseline, week 1, week 2, week 4, week 8, week 12

Secondary Outcomes (2)

• depression change change

  baseline, week 1, week 2, week 4, week 8, week 12

• manic state change

  baseline, week 1, week 2, week 4, week 8, week 12

Other Outcomes (3)

• attention function change

  baseline, week 12

• memory change

  baseline, week 12

• executive functioning change

  baseline, week 12

Study Arms (4)

30 mg DM

EXPERIMENTAL

30mg dextromethorphan+valproate

Drug: Dextromethorphan

5 mg MM

EXPERIMENTAL

5mg memantine+valproate

Drug: Memantine

DM+MM

EXPERIMENTAL

dextromethorphan+memantine+ valproate

Drug: dextromethorphan+memantine

placebo

PLACEBO COMPARATOR

Placebo+valproate

Drug: placebo+valproate

Interventions

Dextromethorphan DRUG

Also known as: 30mg dextromethorphan

30 mg DM

Memantine DRUG

Also known as: 5mg memantine+valproate

5 mg MM

dextromethorphan+memantine DRUG

DM+MM

placebo+valproate DRUG

placebo

Eligibility Criteria

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

You may qualify if:

• A 2-day minimum for hypomania to diagnose bipolar II disorder
• A total of Hamilton Rating Scale for Depression scored at least 18 or Young Mania Rating Scale scored at least 14 at the screening stage
• Must allow to ensure acceptable compliance and visit

You may not qualify if:

• Pregnant females or nursing
• Women of childbearing potential not using adequate contraception
• Received dextromethorphan, memantine, other antiinflammatory medication within 1 week prior
• Clinically significant medical condition (cardiac, hepatic and renal disease)
• Received electroconvulsive therapy patients within 4 weeks prior to the first dose of double-blind medication
• Increase in total SGOT, SGPT, BUN and creatinine by more than 3X upper limit of normal.

Sponsors & Collaborators

• National Cheng-Kung University Hospital: lead

Study Sites (1)

National Cheng Kung University Hospital

Tainan, 704, Taiwan

Location

Related Publications (1)

• Lee SY, Wang TY, Chen SL, Chang YH, Chen PS, Huang SY, Tzeng NS, Wang LJ, Lee IH, Chen KC, Yang YK, Hong JS, Lu RB. Combination of dextromethorphan and memantine in treating bipolar spectrum disorder: a 12-week double-blind randomized clinical trial. Int J Bipolar Disord. 2020 Mar 2;8(1):11. doi: 10.1186/s40345-019-0174-8.

  PMID: 32115672 DERIVED

MeSH Terms

Conditions

Bipolar Disorder

Interventions

Dextromethorphan; Memantine

Condition Hierarchy (Ancestors)

Bipolar and Related Disorders; Mood 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; Amantadine; Adamantane; Bridged-Ring Compounds; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Officials

• Ru-Band Lu, MD

  Department of Psychiatry, National Cheng Kung University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Distinguished Professor

Study Record Dates

• First Submitted: August 29, 2014
• First Posted: February 1, 2017
• Study Start: January 1, 2013
• Primary Completion: December 31, 2016
• Study Completion: December 31, 2017
• Last Updated: July 11, 2017

Record last verified: 2017-07

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)