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Pharmacological Treatment of Depression.


- candidate number2005
- NTR NumberNTR619
- ISRCTNISRCTN73221288
- Date ISRCTN created28-apr-2006
- date ISRCTN requested25-apr-2006
- Date Registered NTR8-mrt-2006
- Secondary IDsN/A 
- Public TitlePharmacological Treatment of Depression.
- Scientific TitleA double-blind study comparing Venlafaxine with imipramine in depressed patients.
- ACRONYMVenla study
- hypothesis1. 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 g/L show comparable antidepressant efficacy as patients with a Venlafaxine plasma level > 195 g/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.
- Healt Condition(s) or Problem(s) studiedDepression
- Inclusion criteriaFor inclusion in the trial, patients must fulfill all of the following criteria:
1. Age 18-65;
2. Major depressive disorder, single or recurrent episode (DSM-IV);
3. HRSD (17 item) >= 14;
4. Written informed consent.
- Exclusion criteriaAny of the following is regarded as a criterion for exclusion from the trial:
1. Patients whom are incapable to understand the information and to give informed consent. And patients whom 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 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 CNS, e.g.: M. Parkinson, SLE, brain tumor, 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: see appendix Moleman P. 1998. Praktische psychofarmacologie. Derde druk. Bohn Stafleu Van Loghum page 19);
12. Direct 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 myocard infarct;
c. Myasthenia gravis;
d. Breastfeeding.
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingDouble
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-jun-2004
- planned closingdate1-jan-2008
- Target number of participants138
- Interventions1. Venlafaxine (maximum dose 375 mg);
2. Imipramine (dose adjustment to adequate plasma levels of 200-300 g/l).
- Primary outcomeChange in HRSD scores.
- Secondary outcome1. 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.
- Timepoints
- Trial web sitehtp://www.erasmusmc.nl/psychiatrie
- statusinclusion stopped: follow-up
- CONTACT FOR PUBLIC QUERIESMD. PhD. W.W. Broek, van den
- CONTACT for SCIENTIFIC QUERIESMD. PhD. W.W. Broek, van den
- Sponsor/Initiator Erasmus Medical Center
- Funding
(Source(s) of Monetary or Material Support)
Wyeth
- PublicationsN/A
- Brief summaryTITLE:
Pharmacological treatment of Depression: Phase I Venlafaxine versus Imipramine

OBJECTIVES:
Primary:
1. To compare in inpatients with a depression the antidepressant efficacy at seven weeks of two treatment arms: (1) 7 weeks Venlafaxine (maximum dose 375 mg); (2) 7 weeks Imipramine (dose adjustment to adequate plasma levels of 200-300 mug/day).
Secondary:
1. To compare in patients with a depression the tolerability of Venlafaxine and Imipramine;
2. Evaluate efficacy and tolerability during continuation of 4 months of treatment in the responders;
3. Measure plasma level of Venlafaxine: Patients with Venlafaxine plasma levels under 195 g/L (not a therapeutical range) show lesser improvement in HRSD/ CGI scores.

TYPE OF PATIENTS:
Inpatients of the Erasmus MC with a severe major depression.

NUMBER OF PATIENTS:
138.

TRIAL DESIGN:
A double blind, randomized singlecentre study with a washout period, comparing 2 treatment strategies.

TRIAL TREATMENTS:
1. Venlafaxine (maximum dose 375 mg);
2. Imipramine (dose adjustment to adequate plasma levels of 200-300 g/l).

DURATION OF TREATMENT:
One week washout and 7 weeks acute treatment with Venlafaxine or Imipramine. Total of 8 weeks;

FOLLOW-UP:
Continuation treatment of responders during 4 months.

PRIMARY ENDPOINTS:
Proportion of responders.
Change in:
1. HRSD scores;
2. CGI scores;
3. Time to response;
4. Adverse effects.
- Main changes (audit trail)
- RECORD8-mrt-2006 - 9-dec-2010


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