Condition category
Mental and Behavioural Disorders
Date applied
27/01/2006
Date assigned
27/01/2006
Last edited
17/08/2009
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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 measures

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

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

Sponsor information

Organisation

Altrecht Mental Health Care (Altrecht Geestelijke Gezondheidszorg [GGZ]) (Netherlands)

Sponsor details

Jutfaseweg 205
Utrecht
3522 HR
Netherlands

Sponsor type

Hospital/treatment centre

Website

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

Results - basic reporting

Publication summary

2007 results in http://www.ncbi.nlm.nih.gov/pubmed/17854241

Publication citations

  1. 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.

Additional files

Editorial Notes