Condition category
Mental and Behavioural Disorders
Date applied
28/04/2006
Date assigned
28/04/2006
Last edited
28/04/2006
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 W.W. Broek, van den

ORCID ID

Contact details

Erasmus Medical Center
Department of Psychiatry
P.O. Box 2040
Rotterdam
3000 CA
Netherlands
w.w.vandenbroek@erasmusmc.nl

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Acronym

Venla study

Study hypothesis

1. Imipramine and Venlafaxine are comparable in efficacy in inpatients with a major depression
2. Imipramine and Venlafaxine are comparable in tolerability
3. Patients with a Venlafaxine plasma level <195 µg/l show comparable antidepressant efficacy as patients with a Venlafaxine plasma level >195 µg/l
4. Imipramine and Venlafaxine are comparable in efficacy during 4 months follow-up
5. Imipramine and Venlafaxine are comparable in tolerability during 4 months follow-up

Ethics approval

Ethics approval received from the local medical ethics committee

Study design

A double blind, randomized single-centre study with a washout period, comparing 2 treatment strategies.

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Condition

Depression

Intervention

1. Venlafaxine (maximum dose 375 mg)
2. Imipramine (dose adjustment to adequate plasma levels of 200-300 µg/l)

Intervention type

Drug

Phase

Not Specified

Drug names

Imipramine, Venlafaxine

Primary outcome measures

Change in HRSD scores.

Secondary outcome measures

1. Change in CGI scores
2. Response defined as >50% reduction on HRSD compared to baseline
3. Remission defined as an end score of <7 on the HRSD

Overall trial start date

01/06/2004

Overall trial end date

01/01/2008

Reason abandoned

Eligibility

Participant inclusion criteria

For inclusion in the trial, patients must fulfill all of the following criteria:
1. Age 18-65
2. Major depressive disorder, single or recurrent episode (Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition [DSM-IV])
3. Hamilton Rating Scale for Depression (HRSD) (17 item) >/= 14
4. Written informed consent

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

138

Participant exclusion criteria

Any of the following is regarded as a criterion for exclusion from the trial:
1. Patients who are incapable of understanding the information and of giving informed consent. Also, patients who are unable to read or write
2. Major depression with psychotic features (separate study)
3. Bipolar I or II disorder
4. Schizophrenia or other primary psychotic disorder
5. Treatment of current episode with adequate trial of Imipramine or Venlafaxine
6. Drug/alcohol dependence in the last 3 months
7. Mental retardation (IQ <80)
8. Women: pregnancy or possibility for pregnancy and no adequate contraceptive measures. Breastfeeding.
9. Serious medical illness affecting central nervous system (CNS) e.g. M. Parkinson, systemic lupus erythematosus (SLE), brain tumor, cerebrovascular accident (CVA)
10. Relevant medical illness as contra-indications for the use of study medication (Venlafaxine and Imipramine), such as recent myocardial infarction and severe liver or kidney failure
11. Medication affecting CNS e.g. antidepressants and/or antipsychotics other than study medication, steroids (prednison), mood stabilisers, benzodiazepines (if not being tapered): >3 mg lorazepam (or equivalent)
12. Direct electroconvulsive therapy (ECT) indication (e.g. very severely suicidal or refusal of food and drinking resulting in life threatening situation)
13. Contra-indications for Lithium (Moleman, 1998):
a. Kidney failure
b. Acute myocardial infarction
c. Myasthenia gravis
d. Breastfeeding

Recruitment start date

01/06/2004

Recruitment end date

01/01/2008

Locations

Countries of recruitment

Netherlands

Trial participating centre

Erasmus Medical Center
Rotterdam
3000 CA
Netherlands

Sponsor information

Organisation

Erasmus Medical Center (The Netherlands)

Sponsor details

P.O. Box 2040
Rotterdam
3000 CA
Netherlands

Sponsor type

University/education

Website

Funders

Funder type

Industry

Funder name

Wyeth

Alternative name(s)

Funding Body Type

private sector organisation

Funding Body Subtype

corporate

Location

United States of America

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

Publication citations

Additional files

Editorial Notes