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Center for Global Research Data

Post hoc patient-level analysis of the impact of amitriptyline, selective serotonin reuptake inhibitors, and placebo of individual items of the Hamilton Depression Rating Scale

Lead Investigator: Elias Eriksson
Title of Proposal Research: Post hoc patient-level analysis of the impact of amitriptyline, selective serotonin reuptake inhibitors, and placebo of individual items of the Hamilton Depression Rating Scale
Vivli Data Request: 7076
Funding Source: University of Gothenburg
Potential Conflicts of Interest: Professor Eriksson has previously been on advisory boards, received speaker’s honoraria, or research grants from H Lundbeck, Janssen-Cilag and Servier. These relationships do not pose a conflict of interest with regard to the current project.

Summary of the Proposed Research:
A long-standing issue in the discussion of antidepressants has been to what extent some of the first generation of these drugs, the tricyclic antidepressants (TCAs, antidepressants with three cyclic structures that work by blocking the reabsorption of the neurotransmitters serotonin and noradrenaline, increasing the levels of these two neurotransmitters in the brain), outperform more modern drugs, such as the selective serotonin reuptake inhibitors (SSRIs, which increase serotonin levels by blocking serotonin reabsorption, but do not affect noradrenaline reabsorption and are more selective in their action, causing fewer side effects than TCAs). This being the case gained support from a recent meta-analysis by Cipriani and co-workers, where the authors combined and compared results from all available trials on commonly used antidepressants.(1) Here, one of the tricyclic compounds, amitriptyline, was ranked as number one of all antidepressants with respect to antidepressant efficacy. This ranking, however, was based on assessments using the sum score of all seventeen symptoms from the Hamilton Depression Rating Scale (HDRS), the most common rating scale used in depression studies. Since sleep symptoms exert a major impact on this measure, however, these results might have been confounded by the prominent sedative properties of amitriptyline. It would hence be of interest to find out if amitriptyline is more effective than the SSRIs in reducing symptoms of depression other than those related to sleep, for example depressed mood, the most common symptom of depression.(2) While amitriptyline, due to its side-effects and possible toxicity at overdose, is nowadays only used as second or third line of treatment for depression, further insight into the relative effects of antidepressants may, needless to say, pave the way for the development of new drugs with superior profile to those currently used.

Requested Studies:
A trial to assess the effectiveness and tolerance of paroxetine by double-blind comparison with amitriptyline in the treatment of depressed patients in General Practice
Data Contributor: GlaxoSmithKline
Study ID: PAR 29060/281
Sponsor ID: PAR 29060/281

A Multicentre Double Blind Study Comparing Paroxetine at a Dose of 20mg Increasing to 30mg Taken in the Morning and Amitriptyline 75mg Increasing to 150mg in Divided Doses in Adult Patients with Major Depressive Disorder
Data Contributor: GlaxoSmithKline
Study ID: PAR 29060/078
Sponsor ID: PAR 29060/078

Early Clinical Evaluation of a New Antidepressant: A Double-Blind Parallel Study Comparing Paroxetine 30mg Daily with Amitriptyline 150mg Daily
Data Contributor: GlaxoSmithKline
Study ID: PAR 29060.316 (HP/82/47A)
Sponsor ID: PAR 29060.316 (HP/82/47A)

Double Blind Parallel Study Comparing Paroxetine, 30mg Daily, and Amitriptyline, 150mg Daily, in Depressed Patients
Data Contributor: GlaxoSmithKline
Study ID: PAR 29060.314 (HP 82/134)
Sponsor ID: PAR 29060.314 (HP 82/134)

Early Clinical Evaluation of a New Antidepressant: Double-Blind Parallel Study Comparing Paroxetine 30mg Daily with Amitriptyline 150mg Daily
Data Contributor: GlaxoSmithKline
Study ID: PAR 29060.310 (HP 81/85A)
Sponsor ID: PAR 29060.310 (HP 81/85A)

Early Clinical Evaluation of a New Antidepressant: A Double-Blind Parallel Study Comparing Paroxetine 30mg Daily with Amitriptyline 100mg Daily
Data Contributor: GlaxoSmithKline
Study ID: PAR 29060.309 HP/81/162A
Sponsor ID: PAR 29060.309 HP/81/162A

Early clinical evaluation of a new antidepressant: A double-blind parallel study comparing paroxetine 30mg daily with amitriptyline 150mg daily
Data Contributor: GlaxoSmithKline
Study ID: PAR 29060.308 (HP/81/74A)
Sponsor ID: PAR 29060.308 (HP/81/74A)

A Multicentre, Double-blind Randomised Dose Titration Study Comparing the Efficacy and Safety Profiles of an Increasing Dose Regimen of Oral Paroxetine and Oral Amitriptyline in Adult Patients with Major Depression
Data Contributor: GlaxoSmithKline
Study ID: MY-059.073/29060/1
Sponsor ID: MY-059.073/29060/1

A Double-Blind Comparison of Paroxetine, Amitriptyline, and Placebo in Inpatients with Major Depressive Disorder with Melancholia
Data Contributor: GlaxoSmithKline
Study ID: 29060/07/001
Sponsor ID: 29060/07/001

A double blind randomised trial comparing the effects on sleep of paroxetine 30mg daily and amitriptyline 150mg daily in patients with major depression.
Data Contributor: GlaxoSmithKline
Study ID: 29060/063
Sponsor ID: 29060/063

Study comparing the effects of oral Paroxetine and Amitriptyline in adult patients with depression
Data Contributor: GlaxoSmithKline
Study ID: PN-MDHU-29060-III-1 (29060/077)
Sponsor ID: PN-MDHU-29060-III-1 (29060/077)

A Multi-Centre General Practice Study to Compare the Effectiveness and Tolerability of Paroxetine in Elderly Depressed Patients by Double Blind Comparison with Amitriptyline
Data Contributor: GlaxoSmithKline
Study ID: PAR MDUK/29060/III/87/049 Hutchinson
Sponsor ID: PAR MDUK/29060/III/87/049 Hutchinson

Assessment of the efficacy and tolerability of paroxetine by double blind comparison with amitriptyline in depressed patients
Data Contributor: GlaxoSmithKline
Study ID: PAR MDSA/29060/III/86/03 (019)
Sponsor ID: PAR MDSA/29060/III/86/03 (019)

An Interim Report of a Study to Assess the Effectiveness and Tolerance of Paroxetine in Depressed Patients by Double-Blind Comparison with Amitriptyline (A follow-up final report was not prepared and is not expected for this study).
Data Contributor: GlaxoSmithKline
Study ID: MDUK/29060/III/85/043
Sponsor ID: MDUK/29060/III/85/043

An Interim Report to Assess the Efficacy and Tolerability of Paroxetine by Double-Blind Comparison with Amitriptyline in Patients Referred to a Psychiatric Clinic
Data Contributor: GlaxoSmithKline
Study ID: MDUK/29060/III/85/028A (PAR 184)
Sponsor ID: MDUK/29060/III/85/028A (PAR 184)

Study comparing the effects of oral Paroxetine and Amitriptyline in adult patients with depression
Data Contributor: GlaxoSmithKline
Study ID: 29060/074
Sponsor ID: 29060/074

A Double Blind Study to Compare the Efficacy and Tolerability of Paroxetine and Amitriptyline in a Multi-Centre General Practice Study in Depressed Patients
Data Contributor: GlaxoSmithKline
Study ID: PAR MDUK 032
Sponsor ID: PAR MDUK 032

Early Clinical Evaluation of a New Antidepressant: A Double-Blind Parallel Study Comparing Paroxetine 30mg Daily with Amitriptyline 150mg Daily
Data Contributor: GlaxoSmithKline
Study ID: PAR 29060.318 (HP/82/64A)
Sponsor ID: PAR 29060.318 (HP/82/64A)

A multi-centre study to assess the effectiveness and tolerance of paroxetine by double-blind comparison with amitriptyline
Data Contributor: GlaxoSmithKline
Study ID: PAR 029060.292
Sponsor ID: PAR 029060.292

A multicentre, double-blind, randomised dose titration study comparing the pharmacodynamics and pharmacokinetics of paroxetine 20mg increasing to 30mg daily and amitriptyline 100mg increasing to 150mg daily in geriatric patients (age >65 years) with major depression.
Data Contributor: GlaxoSmithKline
Study ID: MY-060/BRL-029060/1.
Sponsor ID: MY-060/BRL-029060/1.

A double-blind, short-term comparison of paroxetine and amitriptyline with a 12-month, rater-blind maintenance phase comparing paroxetine, amitriptyline and lithium in the prevention of depressive relapse in patients with major depression, recurrent.
Data Contributor: GlaxoSmithKline
Study ID: BRL-29060/109
Sponsor ID: BRL-29060/109

Paroxetine in the treatment of depression a randomised comparison with amitriptyline.
Data Contributor: GlaxoSmithKline
Study ID: 6121 RAD/Paroxetine/C/4 (PAR 260)
Sponsor ID: 6121 RAD/Paroxetine/C/4 (PAR 260)