NCT01075529

Brief Summary

The purpose of this study is to identify what degree of symptom changes during the early weeks could be used to predict eventual nonresponse at week 6 among depressive inpatients taking fluoxetine.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
140

participants targeted

Target at P50-P75 for phase_4 major-depressive-disorder

Timeline
Completed

Started Mar 2007

Typical duration for phase_4 major-depressive-disorder

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

March 1, 2007

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2010

Completed
23 days until next milestone

First Submitted

Initial submission to the registry

February 24, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 25, 2010

Completed
Last Updated

February 25, 2010

Status Verified

February 1, 2010

Enrollment Period

2.9 years

First QC Date

February 24, 2010

Last Update Submit

February 24, 2010

Conditions

Major Depressive Disorder

Keywords

major depressive disorder, fluoxetine, Hamilton Rating Scale for Depression (HAM-D-17)

Outcome Measures

Primary Outcomes (1)

  • Stable response was defined as a reduction of 50% or more of the HAMD-17 score at week 4 and week 6 of treatment

    6 weeks after initiation of fluxetine

Secondary Outcomes (1)

  • CGI, GAF, Zung's Depression Scale, Short-Form 36, auditory evoked potential, psychomotor speed

    6 weeks after initiation of fluxetine

Study Arms (1)

fluoxetine

NO INTERVENTION
Drug: fluoxetine

Interventions

fluoxetineDRUG

fluoxetine 20 mg/d

fluoxetine

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • diagnosis of major depressive disorder
  • HAM-D-17 ≧17
  • written informed consent

You may not qualify if:

  • Comorbid of substance abuse/dependence
  • Comorbid with mental disorders due to general medical conditions
  • Past history of treatment-resistant depression
  • Severe physical problems
  • pregnant women
  • lactation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kai-Suan Psychiatric Hospital

Kaohsiung City, 802, Taiwan

Location

Related Publications (6)

  • Tollefson GD, Holman SL. How long to onset of antidepressant action: a meta-analysis of patients treated with fluoxetine or placebo. Int Clin Psychopharmacol. 1994 Winter;9(4):245-50. doi: 10.1097/00004850-199400940-00003.

    PMID: 7868846RESULT

  • Bech P. Meta-analysis of placebo-controlled trials with mirtazapine using the core items of the Hamilton Depression Scale as evidence of a pure antidepressive effect in the short-term treatment of major depression. Int J Neuropsychopharmacol. 2001 Dec;4(4):337-45. doi: 10.1017/S1461145701002565.

    PMID: 11806859RESULT

  • Katz MM, Tekell JL, Bowden CL, Brannan S, Houston JP, Berman N, Frazer A. Onset and early behavioral effects of pharmacologically different antidepressants and placebo in depression. Neuropsychopharmacology. 2004 Mar;29(3):566-79. doi: 10.1038/sj.npp.1300341.

    PMID: 14627997RESULT

  • Farabaugh A, Mischoulon D, Fava M, Wu SL, Mascarini A, Tossani E, Alpert JE. The relationship between early changes in the HAMD-17 anxiety/somatization factor items and treatment outcome among depressed outpatients. Int Clin Psychopharmacol. 2005 Mar;20(2):87-91. doi: 10.1097/00004850-200503000-00004.

    PMID: 15729083RESULT

  • Trivedi MH, Morris DW, Grannemann BD, Mahadi S. Symptom clusters as predictors of late response to antidepressant treatment. J Clin Psychiatry. 2005 Aug;66(8):1064-70. doi: 10.4088/jcp.v66n0816.

    PMID: 16086624RESULT

  • Yang WC, Lin CH, Wang FC, Lu MJ. Factors related to the improvement in quality of life for depressed inpatients treated with fluoxetine. BMC Psychiatry. 2017 Aug 25;17(1):309. doi: 10.1186/s12888-017-1471-3.

    PMID: 28841824DERIVED

MeSH Terms

Conditions

Depressive Disorder, Major

Interventions

Fluoxetine

Condition Hierarchy (Ancestors)

Depressive DisorderMood DisordersMental Disorders

Intervention Hierarchy (Ancestors)

PropylaminesAminesOrganic Chemicals

Study Officials

  • Ching-Hua Lin, M.D.

    Kai-Suan Psychiatric Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER GOV

Study Record Dates

First Submitted

February 24, 2010

First Posted

February 25, 2010

Study Start

March 1, 2007

Primary Completion

February 1, 2010

Study Completion

February 1, 2010

Last Updated

February 25, 2010

Record last verified: 2010-02

Locations

TW(1)