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
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