Add-on to Cognitive, Event-Related Potentials (ERP) and E... | NCT03278938

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

NCT03278938

Sponsor

New York State Psychiatric Institute

Status

Withdrawn

Last Update Posted

Mar 15, 2019Actual

Enrollment

0Actual

Phase

Phase 4

Conditions

Depressive Illness

Interventions

bupropion
citalopram

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2019

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

PI Retired and no data was collected

Expanded Access Info

Start Date

Jun 29, 2012Estimated

Primary Completion Date

Jan 2016Estimated

Completion Date

Jan 2016Estimated

First Submitted Date

May 16, 2013

First Submission Date that Met QC Criteria

Sep 7, 2017

First Posted Date

Sep 12, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 13, 2019

Last Update Posted Date

Mar 15, 2019Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
bupropion added to citalopram	Active Comparator	patients who did not remit with citalopram will continue at the same dose and have bupropion added	Drug: bupropion Drug: citalopram
citalopram added to bupropion	Active Comparator	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

Name	Type	Description	Arm Group Labels	Other Names
bupropion	Drug	FDA approved drug for treating depression	bupropion added to citalopram citalopram added to bupropion

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Hamilton Rating Scale	Decrease in score for Hamilton Rating Scale for Depression, 17-item version	weeks 6

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

66 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Jonathan W Stewart, MD	Research Psychiatrist II at New York State Psychiatric Institute	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
New York State Psychiatric Institute		New York	New York	10032	United States

References Module

Citations

Not provided

ID	Term
D001526	Behavioral Symptoms
D001519	Behavior

ID	Term
D016642	Bupropion
D015283	Citalopram

ID	Term
D011427	Propiophenones
D007659	Ketones
D009930	Organic Chemicals
D011437	Propylamines