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

none0 sites69 target enrollmentTBD

ConditionsA double-blind, and randomized singlecenter trial comparing two treatment strategies in patients with a major depression. During phase I patients were treated during 7 weeks with: Imipramine or Venlafaxine. In phase II the non-responders of phase I will be treated with Lithium addition in an open trial during 4 weeks. During these 4 weeks the antidepressant drugs from phase I will be continued at the same dose under maintaining double-blind conditions.

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: A double-blind, and randomized singlecenter trial comparing two treatment strategies in patients with a major depression. During phase I patients were treated during 7 weeks with: Imipramine or Venlafaxine. In phase II the non-responders of phase I will be treated with Lithium addition in an open trial during 4 weeks. During these 4 weeks the antidepressant drugs from phase I will be continued at the same dose under maintaining double-blind conditions.
Sponsor: none
Enrollment: 69
Status: Recruiting
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

Registry

who.int

Start Date

TBD

End Date

TBD

Last Updated

2 years ago

Study Type

Interventional

Investigators

Sponsor

none

Eligibility Criteria

Inclusion Criteria

•All non\-responders in phase I In phase 1 inclusion criteria were:
•1\. Age 18\-65;
•2\. Major depressive disorder, single or recurrent episode (DSM\-IV);
•3\. HRSD (17 item) larger than or equal to 14;
•4\. Written informed consent.

Exclusion Criteria

•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 smaller than 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;

Outcomes

Primary Outcomes

Not specified

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