DepressionNCT00000377
Preventing the Return of Depression in Elderly Patients
A study testing Nortriptyline in people with Depression, run by University of Pittsburgh.
Trial summary
The purpose of this study is to compare the effectiveness of two doses of nortriptyline in elderly patients whose depression returned after stopping treatment. Nortriptyline is an antidepressant. Read more about this study
- Who is it for?
- Ages 60 to 80 years
- Conditions the study is for
- Depression
- What is being tested?
- Nortriptyline
- How many people
- Not given
- Where
- No sites listed yet
- Study dates
- Mar 1989to Apr 2000
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 to 80 years
- All sexes
- Adult, Older adult
Who may be able to join
- -
- Patients must have:
- Recurrence of major depression while in a maintenance placebo condition in the currently funded maintenance therapy protocol (Study I).
Who cannot join
None listed.
About this study
Official title: Maintenance Therapies in Late-Life Depression
The purpose of this study is to compare the effectiveness of two doses of nortriptyline in elderly patients whose depression returned after stopping treatment. Nortriptyline is an antidepressant.
This study enrolls patients who were treated for depression in an earlier research study and whose depression has returned since stopping treatment. Patients are treated for 4 months to bring the depression under control. Patients are then assigned randomly (like tossing a coin) to receive either the full dose of nortriptyline or half the usual dose of nortriptyline. Patients continue taking nortriptyline for 2 years or until a major depression returns. Throughout the study, patients are monitored for symptoms of depression and other side effects.
Read the detailed description
To determine whether elderly (60-80 years old) depressed patients who cannot sustain a remission without medication must be maintained at full acute-treatment dose. To compare the efficacy of full-dose vs half-dose nortriptyline (NT) in preventing recurrences of major depression in the elderly. To determine whether those patients who experience a recurrence while in a maintenance placebo condition (Study I) require 100 percent of their acute-treatment dose of NT to prevent subsequent recurrences or can be successfully maintained on 50 percent of their acute-treatment dose (Study II).
Investigators expect a pool of 60 patients from Study I to become eligible for Study II (the full-dose/half-dose maintenance trial). After treatment of the recurrence and following 16 weeks of stabilization therapy, patients are randomized to 1 of 2 maintenance therapy cells: full-dose NT or half-dose NT. Maintenance lasts 2 years or until recurrence of major depression. The following are assessed: differences in recurrence rates and time to recurrence under full-dose vs half-dose conditions; differences in symptomatic ratings of depression, suicidal ideation, social adjustment, and side effects; and differences in compliance rates as determined by variability in level-to-dose (L/D) ratios. Exploratory data analyses are used to generate a hypothetical profile of elderly patients who can remain well on half-dose maintenance nortriptyline.
For information on related studies, please follow these links:
http://clinicaltrials.gov/show/NCT00178100
http://clinicaltrials.gov/show/NCT00177671
- Conditions
- Depression
- Being tested
- Nortriptyline
- Keywords
- Aged, Antidepressive Agents, Depression, Dose-Response Relationship, Drug, Female, Human, Male, Middle Age, Nortriptyline, Placebos, Recurrence, Aged, 80 and over, Antidepressive Agents -- *therapeutic use, Antidepressive Agents -- administration & dosage, Depression -- *drug therapy, Nortriptyline -- *therapeutic use, Nortriptyline -- administration & dosage
- Medical subject headings
- Depression, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NortriptylineDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 1999 (estimated)
- Study startMar 1989
- Primary completionApr 2000
- Study completionApr 2000
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for DepressionStudies of the same condition, open and under way.
- More trials run by University of PittsburghThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Principal investigator, Charles Reynolds, University of Pittsburgh
- Investigators
- Charles Reynolds, MD, Principal investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00000377
- Sponsor's protocol ID
- R01MH043832
- Other IDs
- R01MH043832, DSIR AT-CT
- Status last verified
- Jun 2013
- First submitted
- 2 Nov 1999
- Last updated
- 21 Jun 2013
- Results posted
- No
Publications
Reynolds CF 3rd, Perel JM, Frank E, Cornes C, Miller MD, Houck PR, Mazumdar S, Stack JA, Pollock BG, Dew MA, Kupfer DJ. Three-year outcomes of maintenance nortriptyline treatment in late-life depression: a study of two fixed plasma levels. Am J Psychiatry. 1999 Aug;156(8):1177-81. doi: 10.1176/ajp.156.8.1177.
PubMed 10450257
Study at a glance
From the registry record, last updated by the sponsor on 21 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Maintenance Therapies in Late-Life Depression
- ClinicalTrials.gov ID
- NCT00000377
- Acronym / sponsor ID
- R01MH043832
- Conditions
- Depression
- Keywords
- Aged, Antidepressive Agents, Depression, Dose-Response Relationship, Drug, Female, Human, Male, Middle Age
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- Mar 1989
- Primary completion
- Apr 2000 (actual)
- Study completion
- Apr 2000 (actual)
- First posted
- 3 Nov 1999 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to compare the effectiveness of two doses of nortriptyline in elderly patients whose depression returned after stopping treatment. Nortriptyline is an antidepressant.
This study enrolls patients who were treated for depression in an earlier research study and whose depression has returned since stopping treatment. Patients are treated for 4 months to bring the depression under control. Patients are then assigned randomly (like tossing a coin) to receive either the full dose of nortriptyline or half the usual dose of nortriptyline. Patients continue taking nortriptyline for 2 years or until a major depression returns. Throughout the study, patients are monitored for symptoms of depression and other side effects.
Detailed description
To determine whether elderly (60-80 years old) depressed patients who cannot sustain a remission without medication must be maintained at full acute-treatment dose. To compare the efficacy of full-dose vs half-dose nortriptyline (NT) in preventing recurrences of major depression in the elderly. To determine whether those patients who experience a recurrence while in a maintenance placebo condition (Study I) require 100 percent of their acute-treatment dose of NT to prevent subsequent recurrences or can be successfully maintained on 50 percent of their acute-treatment dose (Study II).
Investigators expect a pool of 60 patients from Study I to become eligible for Study II (the full-dose/half-dose maintenance trial). After treatment of the recurrence and following 16 weeks of stabilization therapy, patients are randomized to 1 of 2 maintenance therapy cells: full-dose NT or half-dose NT. Maintenance lasts 2 years or until recurrence of major depression. The following are assessed: differences in recurrence rates and time to recurrence under full-dose vs half-dose conditions; differences in symptomatic ratings of depression, suicidal ideation, social adjustment, and side effects; and differences in compliance rates as determined by variability in level-to-dose (L/D) ratios. Exploratory data analyses are used to generate a hypothetical profile of elderly patients who can remain well on half-dose maintenance nortriptyline.
For information on related studies, please follow these links:
http://clinicaltrials.gov/show/NCT00178100
http://clinicaltrials.gov/show/NCT00177671
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
Who may qualify
- Ages
- 60 to 80 years
- Sex
- All
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- -
- Recurrence of major depression while in a maintenance placebo condition in the currently funded maintenance therapy protocol (Study I).
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nortriptyline | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jun 2013.
- Results publication: PubMed 10450257Reynolds CF 3rd, Perel JM, Frank E, Cornes C, Miller MD, Houck PR, Mazumdar S, Stack JA, Pollock BG, Dew MA, Kupfer DJ. Three-year outcomes of maintenance nortriptyline treatment in late-life depression: a study of two fixed plasma levels. Am J Psychiatry. 1999 Aug;156(8):1177-81. doi: 10.1176/ajp.156.8.1177.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Charles Reynolds, MD principal investigator
Questions about this trial
What is this clinical trial studying?
A study testing Nortriptyline in people with Depression, run by University of Pittsburgh.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Jun 2013. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00000377, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jun 2013.