Unipolar DepressionPhase 3NCT01049347
Amitriptyline and Paroxetine Treatment of Major Depression
A Phase 3 study testing amitriptyline and paroxetine in people with Unipolar Depression, run by Central Institute of Mental Health, Mannheim at 1 site in Germany.
Trial summary
Activation of the hypothalamus-pituitary-adrenal system is monitored using saliva cortisol sampling during the antidepressant treatment with amitriptyline and paroxetine in moderately to severely depressed patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Unipolar Depression
- What is being tested?
- amitriptyline and paroxetine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 127 participants
- Where
- 1 siteGermany
- Study dates
- Oct 1997to May 2000
- Phase
- Phase 3
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age: above 18
- depression according DSM-IV
Who cannot join
- bipolar disorder
- substance dependency
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Hypothalamus-pituitary-adrenal System: Role of the Mineralocorticoid Receptor and Longitudinal Study in Depressed Patients
Activation of the hypothalamus-pituitary-adrenal system is monitored using saliva cortisol sampling during the antidepressant treatment with amitriptyline and paroxetine in moderately to severely depressed patients. Additionally, serum and plasma are sampled during the 5-week study period in order to study endocrine and metabolic parameters.
- Conditions
- Unipolar Depression
- Being tested
- amitriptyline, paroxetine
- Keywords
- depression
- Medical subject headings
- Depressive Disorder, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
amitriptylineDrug
150 mg oral, daily, single evening dose, 35 days
paroxetineDrug
40 mg oral, single dose, morning, 35 days
| Study group | Role | What they receive |
|---|---|---|
| amitriptyline | Active comparator | Not described Receives: Drug: amitriptyline |
| paroxetine | Active comparator | Not described Receives: Drug: paroxetine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hamilton Depression Rating Scale (21-item version)
Measured: baseline, weekly assessments for 5 weeks
Secondary outcomes (1)
cortisol in saliva (8.00, 16.00, 22.00) during wash-out (6 days) and 35 days of treatment
Measured: daily during wash-out (days -6 to -1) and active treatment (days 1 to 35)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2010 (estimated)
- Study startOct 1997
- Primary completionMay 2000
- Study completionMay 2000
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Unipolar DepressionStudies of the same condition, open and under way.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 127 participants (actual)
Sponsor and investigators
- Lead sponsor
- Central Institute of Mental Health, Mannheim
- Sponsor type
- University, hospital or other
- Investigators
- Michael Deuschle, MD, Principal investigator, Central Institute of Mental Health, Mannheim
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01049347
- Sponsor's protocol ID
- AmiPar
- Other IDs
- DFG De 660/1-1
- Status last verified
- Jan 2024
- First submitted
- 12 Jan 2010
- Last updated
- 31 Jan 2024
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Schilling C, Gilles M, Blum WF, Daseking E, Colla M, Weber-Hamann B, Lederbogen F, Krumm B, Heuser I, Wudy SA, Kopf D, Deuschle M. Leptin plasma concentrations increase during antidepressant treatment with amitriptyline and mirtazapine, but not paroxetine and venlafaxine: leptin resistance mediated by antihistaminergic activity? J Clin Psychopharmacol. 2013 Feb;33(1):99-103. doi: 10.1097/JCP.0b013e31827cb179.
PubMed 23277262Paslakis G, Kopf D, Westphal S, Gilles M, Lederbogen F, Hamann B, Heuser I, Deuschle M. Treatment with paroxetine, but not amitriptyline, lowers levels of lipoprotein(a) in patients with major depression. J Psychopharmacol. 2011 Oct;25(10):1344-6. doi: 10.1177/0269881110382469. Epub 2010 Oct 15.
PubMed 20952454
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hypothalamus-pituitary-adrenal System: Role of the Mineralocorticoid Receptor and Longitudinal Study in Depressed Patients
- ClinicalTrials.gov ID
- NCT01049347
- Acronym / sponsor ID
- AmiPar
- Conditions
- Unipolar Depression
- Keywords
- depression
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 127 participants (actual)
- Lead sponsor
- Central Institute of Mental Health, MannheimUniversity, hospital or other
- Study start
- Oct 1997
- Primary completion
- May 2000 (actual)
- Study completion
- May 2000 (actual)
- First posted
- 14 Jan 2010 (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.
Activation of the hypothalamus-pituitary-adrenal system is monitored using saliva cortisol sampling during the antidepressant treatment with amitriptyline and paroxetine in moderately to severely depressed patients. Additionally, serum and plasma are sampled during the 5-week study period in order to study endocrine and metabolic parameters.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| amitriptyline | Active comparator | Drug: amitriptyline |
| paroxetine | Active comparator | Drug: paroxetine |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- age: above 18
- depression according DSM-IV
Key exclusion criteria (2 listed)
- bipolar disorder
- substance dependency
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 |
|---|---|---|
| amitriptyline150 mg oral, daily, single evening dose, 35 days | Drug | amitriptyline |
| paroxetine40 mg oral, single dose, morning, 35 days | Drug | paroxetine |
Primary outcome
Hamilton Depression Rating Scale (21-item version)
Time frame: baseline, weekly assessments for 5 weeks
1 secondary outcome
cortisol in saliva (8.00, 16.00, 22.00) during wash-out (6 days) and 35 days of treatment
Time frame: daily during wash-out (days -6 to -1) and active treatment (days 1 to 35)
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 31 Jan 2024.
- Derived from this study: PubMed 23277262Schilling C, Gilles M, Blum WF, Daseking E, Colla M, Weber-Hamann B, Lederbogen F, Krumm B, Heuser I, Wudy SA, Kopf D, Deuschle M. Leptin plasma concentrations increase during antidepressant treatment with amitriptyline and mirtazapine, but not paroxetine and venlafaxine: leptin resistance mediated by antihistaminergic activity? J Clin Psychopharmacol. 2013 Feb;33(1):99-103. doi: 10.1097/JCP.0b013e31827cb179.
- Derived from this study: PubMed 20952454Paslakis G, Kopf D, Westphal S, Gilles M, Lederbogen F, Hamann B, Heuser I, Deuschle M. Treatment with paroxetine, but not amitriptyline, lowers levels of lipoprotein(a) in patients with major depression. J Psychopharmacol. 2011 Oct;25(10):1344-6. doi: 10.1177/0269881110382469. Epub 2010 Oct 15.
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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.
Michael Deuschle, MD principal investigator
Central Institute of Mental Health, Mannheim
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing amitriptyline and paroxetine in people with Unipolar Depression, run by Central Institute of Mental Health, Mannheim at 1 site in Germany.
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 2 inclusion and 2 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 31 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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.
What does the primary outcome measure?
Hamilton Depression Rating Scale (21-item version) (time frame: baseline, weekly assessments for 5 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01049347, which also lists 2 linked publications.
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 31 Jan 2024.