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Trial record 38 of 135 for:    AMITRIPTYLINE

Amitriptyline and Paroxetine Treatment of Major Depression

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01049347
Recruitment Status : Completed
First Posted : January 14, 2010
Last Update Posted : January 14, 2010
Information provided by:
Central Institute of Mental Health, Mannheim

Brief 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. Additionally, serum and plasma are sampled during the 5-week study period in order to study endocrine and metabolic parameters.

Condition or disease Intervention/treatment Phase
Unipolar Depression Drug: amitriptyline Drug: paroxetine Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 127 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Hypothalamus-pituitary-adrenal System: Role of the Mineralocorticoid Receptor and Longitudinal Study in Depressed Patients
Study Start Date : October 1997
Actual Primary Completion Date : May 2000
Actual Study Completion Date : May 2000

Arm Intervention/treatment
Active Comparator: amitriptyline Drug: amitriptyline
150 mg oral, daily, single evening dose, 35 days

Active Comparator: paroxetine Drug: paroxetine
40 mg oral, single dose, morning, 35 days

Primary Outcome Measures :
  1. Hamilton Depression Rating Scale (21-item version) [ Time Frame: baseline, weekly assessments for 5 weeks ]

Secondary Outcome Measures :
  1. 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) ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • age: above 18
  • depression according DSM-IV

Exclusion Criteria:

  • bipolar disorder
  • substance dependency

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01049347

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Central Institute of Mental Health
Mannheim, Germany, 68159
Sponsors and Collaborators
Central Institute of Mental Health, Mannheim
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Principal Investigator: Michael Deuschle, MD Central Institute of Mental Health, Mannheim

Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Prof. Dr. Michael Deuschle, Central Institute of Mental Health Identifier: NCT01049347     History of Changes
Other Study ID Numbers: AmiPar
DFG De 660/1-1 ( Other Grant/Funding Number: German Research Council )
First Posted: January 14, 2010    Key Record Dates
Last Update Posted: January 14, 2010
Last Verified: December 2009
Keywords provided by Central Institute of Mental Health, Mannheim:
Additional relevant MeSH terms:
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Amitriptyline, perphenazine drug combination
Depressive Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Serotonin Agents
Physiological Effects of Drugs
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs
Cytochrome P-450 CYP2D6 Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors
Antidepressive Agents, Tricyclic
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Adrenergic Uptake Inhibitors
Adrenergic Agents
Antipsychotic Agents
Tranquilizing Agents