Pharmacological treatment of psychotic depressio

Completed

• Conditions: In-patients with psychotic depression; Mental and Behavioural Disorders; Depression

• Registration Number: ISRCTN36607067
• Lead Sponsor: niversity Medical Center Utrecht (UMCU) (The Netherlands)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2005-05-16
• Last Update Posted: 13 January 2015

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 160

Inclusion Criteria

1. Aged 18 - 65 years
2. Major depressive disorder, single or recurrent episode, with psychotic features (Diagnostic and Statistical Manual of Mental Disorders, fourth edition [DSM-IV])
3. Hamilton Rating Scale for Depression (HRSD) (17 item)
4. Written informed consent

Exclusion Criteria

Any of the following is regarded as a criterion for exclusion from the trial:
1. Bipolar I or II disorder
2. Schizophrenia or other primary psychotic disorder
3. Treatment of current episode with adequate trial of imipramine or venlafaxine:
3.1. Imipramine at least four weeks with adequate blood levels
3.2. Venlafaxine at least four weeks 300 mg dd
4. Drug/alcohol dependence in the last three months
5. Mental retardation (intelligent quotient [IQ] less than 80)
6. Women:
6.1. Pregnancy or possibility for pregnancy and no adequate contraceptive measures
6.2. Breast-feeding
7. Serious medical illness affecting central nervous system (CNS) e.g. Parkinson's Disease, systemic lupus erythematosus (SLE), brain tumour, cerebrovascular accident (CVA)
8. Relevant medical illness as contra-indications for the use of study medication, such as recent myocardial infarction
9. Medication affecting CNS, e.g. anti-depressives and/or anti-psychotics other than study medication, steroids (prednisone), mood stabilisers, benzodiazepines (if not being tapered): greater than 3 mg lorazepam (or equivalent)
10. Direct electroconvulsive therapy (ECT) indication (e.g. very severe suicidality or refusal of food and drinking resulting in a life threatening situation)
11. Monoamine oxidase inhibitor (MAO-I) less than one week before start of medication free period

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Proportion of responders.

Secondary Outcome Measures

Name	Time	Method
1. Change in:<br>1.1. HRSD scores<br>1.2. Clinical Global Impressions (CGI) scale<br>2. Time to response<br>3. Adverse effects<br>4. Group differences, especially with regard to response to earlier treatments during current episode