NCT00296712

Brief Summary

Relatively drug naive patients will receive two antidepressant medications as initial treatment.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
55

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Feb 2005

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2005

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

February 24, 2006

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 27, 2006

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2006

Completed
Last Updated

April 27, 2012

Status Verified

April 1, 2012

Enrollment Period

1.4 years

First QC Date

February 24, 2006

Last Update Submit

April 26, 2012

Conditions

Major DepressionDysthymiaDepression NOS

Keywords

Major DepressionDysthymiaDepression NOSEscitalopramBupropionDual TherapyCombination Therapy

Outcome Measures

Primary Outcomes (1)

  • Hamilton Depression Scale (HAM-D)

    10 weeks

Secondary Outcomes (4)

  • Beck Depression Inventory (BDI)

    10 weeks

  • Clinical Global Impression Scale (CGI)

    10 weeks

  • Patient Global Impression Scale (PGI)

    10 weeks

  • Arizona Sexual Experience Scale (ASEX)

    10 weeks

Study Arms (1)

escitalopram + bupropion

EXPERIMENTAL

patients begin on escitalopram 10 mg/d, then bupropion 150 mg/d is added and each is alternately increased as tolerated to maximal dose of escitalopram of 40 mg/d and of bupropion of 450 mg/d

Drug: escitalopram + bupropion

Interventions

escitalopram + bupropionDRUG

same dosing as for monotherapy arms

Also known as: escitalopram = Lexapro, bupropion = Wellbutrin
escitalopram + bupropion

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Currently depressed (DSM-IV Major Depression, Dysthymia or Depression NOS)
  • HAMD-D (21-Item) \> 9

You may not qualify if:

  • Prior ineffective adequate trial on either study medication ($ 4 weeks on either escitalopram \>20 mg/d or bupropion \>300 mg/d; \>4 weeks on citalopram \>40 mg/d)
  • History suggesting increased risk for Seizures (e.g., prior Seizure as an adult, diagnosed Seizure Disorder, taking medication known to increase seizure risk, history of significant head trauma, history of Bulimia or Anorexia)
  • History of intolerance to either study medication unless patient and M.D. agree side effect is probably manageable
  • Alcohol and/or drug abuse/dependence during past year
  • Major medical problems that are not well controlled (e.g., untreated hypertension or diabetes)
  • Bipolar I, Bipolar II
  • History of Psychosis, or current Psychosis
  • Currently taking antidepressants or mood stabilizers, which is judged unwise to discontinue (occasional sleep medication or benzodiazepine for Anxiety is allowed)
  • Not currently depressed (whether considered due to current treatment or not)
  • Active suicidal risk (history of suicide attempts will be evaluated on a case by case basis)
  • Pregnant or breast-feeding
  • Premenopausal women not using known effective birth control

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Depression Evaluation Service - New York State Psychiatric Institute

New York, New York, 10032, United States

Location

Related Publications (1)

  • Stewart JW, McGrath PJ, Deliyannides RA, Quitkin FM. Does dual antidepressant therapy as initial treatment hasten and increase remission from depression? J Psychiatr Pract. 2009 Sep;15(5):337-45. doi: 10.1097/01.pra.0000361276.88339.44.

    PMID: 19820552DERIVED

Related Links

MeSH Terms

Conditions

Depressive Disorder, MajorDysthymic DisorderDepression

Interventions

EscitalopramBupropion

Condition Hierarchy (Ancestors)

Depressive DisorderMood DisordersMental DisordersBehavioral SymptomsBehavior

Intervention Hierarchy (Ancestors)

PropylaminesAminesOrganic ChemicalsNitrilesBenzofuransHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsPropiophenonesKetones

Study Officials

  • Jonathan W. Stewart, MD.

    New York State Psychiatric Institute - Columbia University Department of Psychiatry

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 24, 2006

First Posted

February 27, 2006

Study Start

February 1, 2005

Primary Completion

July 1, 2006

Study Completion

July 1, 2006

Last Updated

April 27, 2012

Record last verified: 2012-04

Locations

US(1)