Condition category
Mental and Behavioural Disorders
Date applied
20/12/2005
Date assigned
20/12/2005
Last edited
06/07/2009
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Hein Hout, van

ORCID ID

Contact details

VU University Medical Centre
EMGO-Institute
Department of General Practice
Van der Boechorststraat 7
Amsterdam
1081 BT
Netherlands

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

NTR178; OOG00-020

Study information

Scientific title

Acronym

HOMiD

Study hypothesis

Antidepressant medication does not add any effect to usual consultations by general practitioners in patients with minor and mild-major depression

Ethics approval

Received from local medical ethics committee

Study design

Multicentre, randomised, active controlled, parallel group trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

GP practices

Trial type

Treatment

Patient information sheet

Condition

Depression

Intervention

Patients were randomly assigned to four sessions of counselling during 3 months with (n=85) or without paroxetine (n=96). Both treatments were carried out by the patient’s own GP.

Intervention type

Drug

Phase

Not Specified

Drug names

paroxetine

Primary outcome measures

1. Severity of Depressive by MADRS (Montgomery Åsberg Depression Rating Scale)
2. Remission of depression by MADRS score<10

Secondary outcome measures

1. Quality of Live (Short Form 36)
2. Subjective depression (Beck Depression. Inventory)
3. Client Satisfaction Questionnaire
4. Direct and indirect costs

Overall trial start date

01/01/2002

Overall trial end date

01/05/2005

Reason abandoned

Eligibility

Participant inclusion criteria

1. Aged 18 years or over
2. Having 3-6 out of 9 depressive symptoms for at least 2 weeks for most days of the week, including at least one of the core symptoms ‘sadness’ or ‘loss of pleasure’. Impairment by depressive symptoms in social, occupational or other important areas of functioning (minor depression=3-4 symptoms, mild-major depression=5-6 symptoms)

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

181

Participant exclusion criteria

1. Current intake of antidepressants or receiving psychological therapy
2. Psychotic features
3. Alcohol or drug addiction
4. Loss of a loved one or significant other in the past six months
5. Pregnancy or breastfeeding
6. Inability to complete questionnaires because of language difficulties, illiteracy or cognitive decline
7. Not having a telephone

Recruitment start date

01/01/2002

Recruitment end date

01/05/2005

Locations

Countries of recruitment

Netherlands

Trial participating centre

VU University Medical Centre,
Amsterdam
1081 BT
Netherlands

Sponsor information

Organisation

EMGO Institute (Netherlands)

Sponsor details

Van der Boechorststraat 7
Amsterdam
1081 BT
Netherlands
+31 20 4448180
emgo@vumc.nl

Sponsor type

Not defined

Website

Funders

Funder type

Government

Funder name

The Health Care Insurance Board (CVZ) (Netherlands)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2007 results in http://www.ncbi.nlm.nih.gov/pubmed/18067659

Publication citations

  1. Results

    Hermens ML, van Hout HP, Terluin B, Adèr HJ, Penninx BW, van Marwijk HW, Bosmans JE, van Dyck R, de Haan M, Clinical effectiveness of usual care with or without antidepressant medication for primary care patients with minor or mild-major depression: a randomized equivalence trial., BMC Med, 2007, 5, 36, doi: 10.1186/1741-7015-5-36.

Additional files

Editorial Notes