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WithdrawnNCT03278938Updated Mar 15, 2019

Add-on to Cognitive, Event-Related Potentials (ERP) and Electroencephalogram (EEG) Asymmetry in Affective Disorders

A Phase 4 interventional study of bupropion and citalopram in Depressive Illness, sponsored by New York State Psychiatric Institute. Withdrawn at 1 site in United States. Open to participants aged 18 Years to 66 Years. Per ClinicalTrials.gov, last updated 2019-03-15.

Sponsored by New York State Psychiatric Institute · Phase 4, Interventional, and Treatment

Why this study was withdrawn
PI Retired and no data was collected
Phase
Phase 4
Study type
Interventional
Enrollment
0
Allocation
Non-randomized
Ages
18 Years to 66 Years
Sex
All
01

Study summary

Depressed patients unremitted after monotherapy with citalopram or bupropion will remit following six weeks treatment with the combination of citalopram and bupropion.

Read the detailed description

Participants in another study who did not remit during 12 weeks treatment with citalopram (to 40 mg/d) or bupropion (to 450 mg/d) will have citalopram (to 40 mg/d) or bupropion (to 450 mg/d) added for six weeks.

02

Conditions studied

  • Depressive Illness

Keywords

  • depression
  • citalopram
  • bupropion
  • combination therapy
03

Who can participate

Ages eligible
18 Years to 66 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • non-remission in Protocol #6559R
  • age 18-66
  • signs informed consent
  • physically healthy

Exclusion criteria

Exclusion Criteria:

  • bipolar disorder
  • history of psychosis
  • history of anorexia nervosa or bulimia
  • history of seizure disorder, significant brain trauma or other medical reason to suspect increased seizure risk
04

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
0 participants (actual)

Study arms

  • Active comparator
    bupropion added to citalopram

    patients who did not remit with citalopram will continue at the same dose and have bupropion added

    Drug: bupropion · Drug: citalopram

  • Active comparator
    citalopram added to bupropion

    Patients who did not remit with bupropion will have bupropion continued at the same dose and citalopram will be added

    Drug: bupropion · Drug: citalopram

Interventions

  • Drugbupropion

    FDA approved drug for treating depression

    Also known as: Wellbutrin

  • Drugcitalopram

    FDA approved treatment for depression

    Also known as: Celexa

05

What researchers measure

Primary outcomes

  1. Hamilton Rating Scale

    Decrease in score for Hamilton Rating Scale for Depression, 17-item version

    Time frame: weeks 6

06

Study locations

1 site
  • New York State Psychiatric Institute
    New York, New York 10032, United States
07

References and documents

08

Registry details

Key details

Study ID
NCT03278938
Lead sponsor
New York State Psychiatric Institute
Responsible party
Sponsor
First posted
Sep 12, 2017
Start date
Jun 29, 2012 (estimated)
Primary completion
Jan 2016 (estimated)
Completion
Jan 2016 (estimated)
Last update
Mar 15, 2019

Study contacts

Jonathan W Stewart, MD
principal investigator · Research Psychiatrist II at New York State Psychiatric Institute

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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This study is withdrawn, as verified in Mar 2019. You cannot join it, but the record below documents what was studied.

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