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Pharmacological treatment of psychotic depression.

Pharmacological treatment of psychotic depression.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON24572
Enrollment
160
Registered
2004-12-23
Start date
2002-03-01
Completion date
Unknown
Last updated
2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Trial treatments: 1 Venlafaxine (maximum dose 375 mg). 2. Imipramine (dose adjustment to adequate plasma levels of 200 – 300 ug/L). 3. Venlafaxine (maximum dose 375 mg) plus quetiapine (max. 600 mg

Sponsors

None listed

Eligibility

Inclusion criteria

Inclusion criteria: 1. Age 18-65; 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) 18; 4. Written informed consent.

Exclusion criteria

Exclusion criteria: 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. - imipramine at least 4 weeks with adequate bloodlevels; - venlafaxine at least 4 weeks ? 300 mg dd; 4. Drug/alcohol dependence last 3 months; 5. Mental retardation (IQ 3 mg lorazepam (or equivalent: see appendix ‘Moleman P. 1998. Praktische psychofarmacologie. Derde druk. Bohn Stafleu Van Loghum. page 19’); 10. Direct ECT indication (e.g. very severe suicidality or refusal of food and drinking resulting in a life threatening situation); 11. MAO-I < 1 week before start of medication free period.

Design outcomes

Primary

MeasureTime frame
Proportion of responders.

Secondary

MeasureTime frame
1a. Change in HRSD scores; 1b. Change in CGI scores; 2. Time to response; 3. Adverse effects; 4. Group differences especially with regard to response to earlier treatments during current episode.

Contacts

Public ContactJ. Wijkstra

University Medical Center Utrecht (UMCU), B01.206, Department of Psychiatry, P.O. Box 85500

J.Wijkstra@azu.nl+31 (0)30 2508178

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)