Ketamine in treatment-resistant major depressio

Completed

• Conditions: Treatment-resistant major depression; Mental and Behavioural Disorders; Depression

• Registration Number: ISRCTN28417759
• Lead Sponsor: niversity of Kuopio (Finland)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2006-07-03
• Last Update Posted: 13 January 2015

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

1. Major depression disorder (Diagnostic and Statistical Manual of mental disorders [DSM-IV] 296.2 or 296.3) or type two bipolar affective disorder, last phase with depressive symptoms
2. Depressive symptoms at least at moderate level (Hamilton Depression rating scale [HAMD-17] score 16 or more)
3. Age 18 to 55 years
4. Insufficient response to at least two different antidepressants
5. No substantial changes in current antidepressant treatment during the last four weeks and changes in pharmacotherapy have not been planned for the following two weeks

Exclusion Criteria

1. Serious somatic disease (cardiac insufficiency, untreated hypertension, increased cerebral pressure, diseases in the central nervous system, increased intraocular pressure (glaucoma), hepatic disease, porphyria, thyroid disease, infection in lungs or in upper respiratory track, epilepsy)
2. Theophyllin medication, or use of anticonvulsants or drugs affecting glutamatergic system
3. Proneness to psychotic symptoms (psychosis diagnosed in first degree relatives)
4. Increased suicide risk
5. Pregnancy
6. Substance abuse during the last three weeks
7. Exceptionally large dosage of antidepressants (dosage per day more than recommended in Pharmaca Fennica) (this was amended 19/12/2006)
8. Exceptionally large dosage of benzodiazepines (diazepam equivalent dose more than 30 mg/day)

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in HAMD-17 scores during the first seven days after infusion compared with scores on control day (before infusion).

Secondary Outcome Measures

Name	Time	Method
1. 15-D instrument to indicate quality of life<br>2. HAMD/ Melancholia Scale (MES) <br>3. Symptom Checklist 90-scale (SCL-90)