A Pilot Study Assessing Duloxetine's Efficacy in Atypical Depression

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Primary Purpose

Status

Completed

Phase

Phase 4

Locations

United States

Study Type

Interventional

Intervention

Duloxetine

About this trial

This is an interventional treatment trial for Atypical Depression focused on measuring Atypical Depression, Major Depressive Disorder, Dysthymic Disorder, Atypical Features, Duloxetine

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: DSM-IV Major Depression or Dysthymia with Atypical Features Age 18-65 Physically healthy HAMD(24) > 14 Exclusion Criteria: Prior experience with Duloxetine History of Psychosis or Bipolar Disorder, Borderline Personality Disorder Unstable medical disorder; any history of Epilepsy Currently taking medication that can interact with Duloxetine Current (past six months) Substance Use Disorder (illicit drugs and/or alcohol) Serious suicidal ideation judged at least somewhat likely to be acted upon or require hospitalization Current (past two weeks) use of psychoactive medication (four weeks for Fluoxetine) Pregnancy Currently breast feeding Fecund women failing to use acceptable birth control Refractory Depression (defined as failure to respond to one or more adequate trials of marketed antidepressants [i.e., >=2/3 PDR maximum dose for at least 4 weeks] during current episode) Serious suicidal ideation, recent (past six months) suicidal activity, any life-time history of serious suicide attempt (e.g., admitted to ICU, any duration of coma) Currently taking medication deemed effective

Sites / Locations

Depression Evaluation Service - New York State Psychiatric Institute

Outcomes

Primary Outcome Measures

Hamilton Depression Scale (HAM-D)

Secondary Outcome Measures

Atypical Depression Diagnostic Scale (ADDS)

Beck Depression Inventory (BDI)

Clinical Global Impression (CGI)

Patient Global Impression (PGI)

Inventory of Depressive Symptoms(IDS)

Full Information

NCT ID

NCT00296699

First Posted

February 23, 2006

Last Updated

January 14, 2008

Sponsor

New York State Psychiatric Institute

Collaborators

Eli Lilly and Company

1. Study Identification

Unique Protocol Identification Number

NCT00296699

Brief Title

A Pilot Study Assessing Duloxetine's Efficacy in Atypical Depression

Official Title

A Pilot Study Assessing Duloxetine's Efficacy in Atypical Depression

Study Type

Interventional

2. Study Status

Record Verification Date

January 2008

Overall Recruitment Status

Completed

Study Start Date

March 2005 (undefined)

Primary Completion Date

June 2007 (Actual)

Study Completion Date

undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor

New York State Psychiatric Institute

Collaborators

Eli Lilly and Company

4. Oversight

5. Study Description

Brief Summary

This is a Pilot Study to get a first indication whether Duloxetine may be effective for depressed patients with Atypical Features.

Detailed Description

This Open Pilot Study will assess whether Duloxetine is effective for patients with Atypical Features. 20 patients having Major Depressive Disorder with Atypical Features or Dysthymic Disorder will receive Duloxetine in open fashion for 8 weeks. Dose will begin with 20 mg/d and increase to PDR maximal dose of 120 mg/d, if tolerated.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Atypical Depression

Keywords

Atypical Depression, Major Depressive Disorder, Dysthymic Disorder, Atypical Features, Duloxetine

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

20 (Actual)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

Duloxetine

Other Intervention Name(s)

Cymbalta

Intervention Description

Day 1-7: 20 mg/d; day 8-24: 30 mg/d; day 15-28: 60 mg/d; day 29-56: 120 mg/d. * dose raises will occur only if pt. is tolerating the previous dose and not remitting.; dose may be lowered or increased in 30 mg increments if pt. has difficulty tolerating.

Primary Outcome Measure Information:

Title

Hamilton Depression Scale (HAM-D)

Time Frame

10 weeks

Secondary Outcome Measure Information:

Title

Atypical Depression Diagnostic Scale (ADDS)

Time Frame

10 weeks

Title

Beck Depression Inventory (BDI)

Time Frame

10 weeks

Title

Clinical Global Impression (CGI)

Time Frame

10 weeks

Title

Patient Global Impression (PGI)

Time Frame

10 weeks

Title

Inventory of Depressive Symptoms(IDS)

Time Frame

10 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

No

Eligibility Criteria

Inclusion Criteria: DSM-IV Major Depression or Dysthymia with Atypical Features Age 18-65 Physically healthy HAMD(24) > 14 Exclusion Criteria: Prior experience with Duloxetine History of Psychosis or Bipolar Disorder, Borderline Personality Disorder Unstable medical disorder; any history of Epilepsy Currently taking medication that can interact with Duloxetine Current (past six months) Substance Use Disorder (illicit drugs and/or alcohol) Serious suicidal ideation judged at least somewhat likely to be acted upon or require hospitalization Current (past two weeks) use of psychoactive medication (four weeks for Fluoxetine) Pregnancy Currently breast feeding Fecund women failing to use acceptable birth control Refractory Depression (defined as failure to respond to one or more adequate trials of marketed antidepressants [i.e., >=2/3 PDR maximum dose for at least 4 weeks] during current episode) Serious suicidal ideation, recent (past six months) suicidal activity, any life-time history of serious suicide attempt (e.g., admitted to ICU, any duration of coma) Currently taking medication deemed effective

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jonathan W. Stewart, M.D.

Organizational Affiliation

New York State Psychiatric Institute - Columbia University Department of Psychiatry

Official's Role

Principal Investigator

Facility Information:

Facility Name

Depression Evaluation Service - New York State Psychiatric Institute

City

New York

State/Province

New York

ZIP/Postal Code

10032

Country

United States

12. IPD Sharing Statement

Links:

URL

http://www.depression-nyc.org

Description

Depression Evaluation Service - official website

URL

http://www.nyspi.org

Description

New York State Psychiatric Institute - official website

Atypical Depression

About this trial

Eligibility Criteria

Sites / Locations

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial