Ketamine in treatment-resistant major depression
| ISRCTN | ISRCTN28417759 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN28417759 |
| EudraCT/CTIS number | 2006-001798-95 |
| Secondary identifying numbers | 170965 |
- Submission date
- 05/06/2006
- Registration date
- 03/07/2006
- Last edited
- 04/02/2015
- Recruitment status
- Stopped
- Overall study status
- Stopped
- Condition category
- Mental and Behavioural Disorders
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Prof Jari Tiihonen
Scientific
Scientific
Niuvanniemi Hospital
Kuopio
FI-70240
Finland
Study information
| Study design | Randomised placebo-controlled parallel-group multi-centre trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised parallel trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Scientific title | Ketamine in treatment-resistant major depression |
| Study objectives | 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(s) | 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 |
| Health condition(s) or problem(s) studied | Treatment-resistant major depression |
| Intervention | Ketamine-infusion (0.5 mg/kg) or placebo-infusion (0.9 % NaCl) during 40 minutes. |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Ketamine |
| Primary outcome measure | 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 study start date | 09/06/2006 |
| Completion date | 30/09/2007 |
| Reason abandoned (if study stopped) | Participant recruitment issue |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 100 patients |
| Key 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 |
| Key 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) |
| Date of first enrolment | 09/06/2006 |
| Date of final enrolment | 30/09/2007 |
Locations
Countries of recruitment
- Finland
Study participating centre
Niuvanniemi Hospital
Kuopio
FI-70240
Finland
FI-70240
Finland
Sponsor information
University of Kuopio (Finland)
University/education
University/education
PO Box 1627
Kuopio
FI-70211
Finland
| Website | http://www.uku.fi/english/ |
|---|---|
"ROR" |
https://ror.org/00cyydd11 |
Funders
Funder type
Hospital/treatment centre
Niuvanniemi Hospital (Finland)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
