Condition category
Mental and Behavioural Disorders
Date applied
05/06/2006
Date assigned
03/07/2006
Last edited
04/02/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Stopped
Recruitment status
Stopped

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Jari Tiihonen

ORCID ID

Contact details

Niuvanniemi Hospital
Kuopio
FI-70240
Finland

Additional identifiers

EudraCT number

2006-001798-95

ClinicalTrials.gov number

Protocol/serial number

170965

Study information

Scientific title

Ketamine in treatment-resistant major depression

Acronym

Study hypothesis

The purpose of this trial is to study if ketamine-infusion relieves symptoms of depression among patients, who have not obtained sufficient response from conventional treatment. The study is a randomised, placebo-controlled, parallel-group trial.

Updated 04/02/2015: the trial was stopped on 14/08/2007 due to major difficulties in recruiting eligible subjects.

Ethics approval

The Ethical Committee of the Northern Savo Hospital District (formerly "The ethical committee of University of Kuopio and Kuopio University Hospital"), approval was dated 14/03/2006 (ref: 30/2006). The study was also approved by the National Agency for Medicines on 12/05/2006 (ref: 81/2006).

The Ethical Committee of the Northern Savo Hospital District has approved the amendment of the exclusion criteria on 12/12/2006

Study design

Randomised placebo-controlled parallel-group multi-centre trial

Primary study design

Interventional

Secondary study design

Randomised parallel trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

Treatment-resistant major depression

Intervention

Ketamine-infusion (0.5 mg/kg) or placebo-infusion (0.9 % NaCl) during 40 minutes.

Intervention type

Drug

Phase

Not Applicable

Drug names

Ketamine

Primary outcome measures

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

Secondary outcome measures

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

Overall trial start date

09/06/2006

Overall trial end date

30/09/2007

Reason abandoned

Participant recruitment issue

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

100 patients

Participant 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)

Recruitment start date

09/06/2006

Recruitment end date

30/09/2007

Locations

Countries of recruitment

Finland

Trial participating centre

Niuvanniemi Hospital
Kuopio
FI-70240
Finland

Sponsor information

Organisation

University of Kuopio (Finland)

Sponsor details

PO Box 1627
Kuopio
FI-70211
Finland

Sponsor type

University/education

Website

http://www.uku.fi/english/

Funders

Funder type

Hospital/treatment centre

Funder name

Niuvanniemi Hospital (Finland)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes