NCT00325000

Brief Summary

We examined the hypotheses that severely depressed inpatients treated for 5 weeks with IPT-S plus pharmacotherapy have 1) a higher reduction in depressive symptoms and 2) higher response- and remission rates compared to pharmacotherapy plus CM. For the follow-up period (12 months) we hypothesized a better symptomatic and psychosocial longterm outcome and lower rates of relapse for patients initially treated with combination therapy.

Trial Health

57
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Trial Health Score

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

Timeline
Completed

Started Nov 2000

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2000

Completed
3.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2004

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

May 9, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 11, 2006

Completed
Last Updated

December 20, 2006

Status Verified

October 1, 2000

First QC Date

May 9, 2006

Last Update Submit

December 19, 2006

Conditions

Major Depression

Outcome Measures

Primary Outcomes (1)

  • The 17-item version of the Hamilton Rating Scale for Depression (HAMD) served as the primary outcome measure

Secondary Outcomes (1)

  • Beck Depression Inventory

Interventions

Interpersonal PsychotherapyBEHAVIORAL
sertraline or amitriptylineDRUG

Eligibility Criteria

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

You may qualify if:

  • Major Depression (single episode, recurrent or bipolar II) according to the Structured Clinical Interview for DSM IV (SCID)and a score of ≥ 16 on the 17-item version of the Hamilton Rating Scale for Depression (HAMD)

You may not qualify if:

  • (1) concurrent diagnosis of bipolar I disorder, primary substance abuse or dependency, mental disorder due to organic factors, and borderline or antisocial personality disorder, (2) psychotic symptoms, (3) severe cognitive impairment, (4) contraindications to the study medication, and (5) being actively suicidal

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Clinic Freiburg , Dept. of Psychiatry and Psychotherapy

Freiburg im Breisgau, 79104, Germany

Location

MeSH Terms

Conditions

Depressive Disorder, Major

Interventions

Interpersonal PsychotherapySertralineAmitriptyline

Condition Hierarchy (Ancestors)

Depressive DisorderMood DisordersMental Disorders

Intervention Hierarchy (Ancestors)

PsychotherapyBehavioral Disciplines and Activities1-NaphthylamineAminesOrganic ChemicalsNaphthalenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsPolycyclic CompoundsDibenzocycloheptenesBenzocycloheptenes

Study Officials

  • Mathias Berger, MD

    University Clinic Freiburg, Dept. of Psychiatry and Psychotherapy

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

May 9, 2006

First Posted

May 11, 2006

Study Start

November 1, 2000

Study Completion

August 1, 2004

Last Updated

December 20, 2006

Record last verified: 2000-10

Locations

DE(1)