Contact information
Type
Scientific
Primary contact
Dr Rob M. Kok
ORCID ID
Contact details
Altrecht GGZ
Jutfaseweg 205
Utrecht
3522 HR
Netherlands
+31 (0)30 2297600
r.kok@altrecht.nl
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
NTR453; 1360.0001
Study information
Scientific title
Acronym
Study hypothesis
Both active medications are equally effective in the treatment of non-responding elderly patients but phenelzine is better tolerated than lithium.
Ethics approval
Received from local medical ethics committee
Study design
Randomised single blind active controlled parallel group trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Other
Trial type
Treatment
Patient information sheet
Condition
Depression
Intervention
Patients start with either phenelzine 15 mg or lithiumcarbonate 200 mg. The dose will be increased with phenelzine 15 mg or lithiumcarbonate 200 mg after 4-8 days.
The minimum daily dose of phenelzine is 15 mg and the maximum daily dose is 60 mg. Lithium is dosed to reach a serum level between 0.6-0.8 mmol/l.
Intervention type
Drug
Phase
Not Specified
Drug names
Phenelzine, lithiumcarbonate
Primary outcome measure
Efficacy: remission defined as a final score of 10 or less on the MADRS.
Tolerability: Global Tolerability Score.
Secondary outcome measures
1. Response defined as a reduction of at least 50% of MADRS, Hamilton Depression Scale (HAM-D) and Geriatric Depression Scale (GDS), Clinical Global Impression (CGI) 1-2
2. Remission on HAM-D, GDS
3. Number of (serious) side effects and drop out rate due to the study medication
4. MMSE-score, Trail Making Test (TMT), Dutch Verbal Learning and Memory Test (Verbale Leer en Geheugen Test [VLGT]) (cognitive tests)
Overall trial start date
01/01/2000
Overall trial end date
01/01/2005
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Male or female inpatient
2. Aged 60 years or older
3. Meet the Diagnostic and Statistical Manual of Mental Disorders (DSM-IV) criteria for major depression, single or recurrent episode (296.2x, 296.3x)
4. Non-response to adequate treatment with a tricyclic antidepressant (minimal 4-6 weeks with serum levels within therapeutic window) or venlafaxine (minimal 4-6 weeks with a sum serum level of venlafaxine+ O-desmethylvenlafaxine >200 microgram)
5. Have a baseline total score of at least 20 on the Montgomery-Asberg Depression Rating Scale (MADRS)
6. Have a Mini Mental State Examination (MMSE) score >15
7. In the opinion of the investigator, have sufficient intelligence and motivation to comply with, and is competent to understand, the study procedures (especially dietary instructions in case of phenelzine)
8. Sign the written informed consent
Participant type
Patient
Age group
Senior
Gender
Both
Target number of participants
30
Participant exclusion criteria
1. Known hypersensitivity to lithium or phenelzine
2. Previous unsuccessful adequate (minimal 15 mg during 4 weeks) treatment with phenelzine or with lithiumaugmentation (minimal serum level of 0.6 mmol/l during 4 weeks)
3. Use of lithium or phenelzine within 30 days prior to baseline, use of a MonoAmine Oxide (MAO) inhibitor within 14 days, use of fluoxetine within 21 days, use of any other psychotropic drug (except antidepressants and those allowed during the study as concomitant treatment) within 7 days prior to baseline
4. The presence of a physical illness which seriously interacts with treatment with either lithium or phenelzine
5. Alcohol or drug abuse within the last 2 years, according to DSM IV criteria
6. Presence of dementia or non-affective psychotic disorder, history of bipolar disorder (I and II)
7. Concomitant use of alcohol or drugs that can have serious interactions with phenelzine or lithium
Recruitment start date
01/01/2000
Recruitment end date
01/01/2005
Locations
Countries of recruitment
Netherlands
Trial participating centre
Altrecht GGZ
Utrecht
3522 HR
Netherlands
Funders
Funder type
Research organisation
Funder name
Netherlands Organisation for Health Research and Development (ZonMw) (Netherlands)
Alternative name(s)
Netherlands Organisation for Health Research and Development
Funding Body Type
private sector organisation
Funding Body Subtype
other non-profit
Location
Netherlands
Funder name
Parke Davis (USA)
Alternative name(s)
Parke Davis & Company
Funding Body Type
private sector organisation
Funding Body Subtype
corporate
Location
United States of America
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
Basic results (scientific)
Publication list
2007 results in http://www.ncbi.nlm.nih.gov/pubmed/17854241
Publication citations
-
Results
Kok RM, Vink D, Heeren TJ, Nolen WA, Lithium augmentation compared with phenelzine in treatment-resistant depression in the elderly: an open, randomized, controlled trial., J Clin Psychiatry, 2007, 68, 8, 1177-1185.