Clinical Trials Logo
  1. Home
  2. Depressive Disorder, Major
  3. NCT00406952
  4. Details
NCT00406952 Clinical Trial

Study for Evaluating Different Methods of Measuring Depression Treatment Response

Depressive Disorder, Major Clinical Trial

Official title:
A Phase 4 Randomized, Double-Blind, Placebo Controlled Methodology Study to Evaluate the Time of Onset of AntiDepressant Response in Subjects With Major Depressive Disorder

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00406952
Other study ID # A9001337
Secondary ID
Status Completed
Phase N/A
First received November 30, 2006
Last updated August 20, 2008
Start date November 2006
Est. completion date August 2007

Study information
Verified date August 2008
Source Pfizer
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

Purpose of the study is to evaluate use of electronic diaries and voice acoustics for use in future depression clinical trial. Focus is on increased precision of measurement.

Recruitment information / eligibility
Status Completed
Enrollment 165
Est. completion date August 2007
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria:

- Primary diagnosis of Major Depressive Disorder with symptoms of depression present at least 1 month

- Psychotropic medications currently not being taken

Exclusion Criteria:

- Failure to respond in past 5 years to antidepressant therapy of adequate duration and dosing

- Diagnoses of following conditions or disorders within past 6 months: generalized anxiety, obsessive compulsive, panic, post stress, anorexia, bulimia, alcohol or substance abuse or social anxiety disorder

- Diagnoses current or past of the following conditions or disorders: schizophrenia, psychotic disorder, delieium, dememtia, amnestic cognitive disorder, bipolar

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Procedure:
• electronic diary

Drug:
• Sertraline

• Placebo

Procedure:
• voice acoustics

Locations
Country Name City State
United States Pfizer Investigational Site Atlanta Georgia
United States Pfizer Investigational Site Aventura Florida
United States Pfizer Investigational Site Elmsford New York
United States Pfizer Investigational Site Jacksonville Florida
United States Pfizer Investigational Site Memphis Tennessee
United States Pfizer Investigational Site Miami Florida
United States Pfizer Investigational Site Miami Florida
United States Pfizer Investigational Site Miami Florida
United States Pfizer Investigational Site Midvale Utah
United States Pfizer Investigational Site Norwich Connecticut
United States Pfizer Investigational Site Orlando Florida
United States Pfizer Investigational Site Plano Texas

Sponsors (1)
Lead Sponsor Collaborator
Pfizer

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary The primary endpoint is time to treatment response and difference in time to response for the two data collection methods - daily patient electronic assessment versus weekly assessments measured in clinic.
Secondary The secondary endpoint is the difference in study participation burden between standard and enhanced data collection.
See also
  Status Clinical Trial Phase
Recruiting NCT05915013 - Alpha-Amino-3-Hydroxy-5-Methyl-4- Isoxazole Propionic Acid Receptor Components of the Anti-Depressant Ketamine Response Phase 1
Completed NCT04469322 - Pharmacogenetic Implementation Trial in Veterans With Treatment Refractory Depression N/A
Recruiting NCT05415397 - Treating Immuno-metabolic Depression With Anti-inflammatory Drugs Phase 3
Recruiting NCT05988333 - Psychoeducational Intervention for Families With a Member Affected by Major Depression N/A
Completed NCT02919501 - Study of the Efficacy and Safety of Initial Administration of 17 mg Vortioxetine Intravenously With 10 mg/Day Vortioxetine Orally in Patients With Major Depressive Disorder Phase 2
Completed NCT00976560 - Clinical Study to Test a New Drug to Treat Major Depression Phase 2
Recruiting NCT05518149 - A Study of Aticaprant in Adult and Elderly Participants With Major Depressive Disorder (MDD) Phase 3
Not yet recruiting NCT06303076 - Tizanidine vs. Zolpidem in Primary Insomnia: A Randomized Trial Phase 4
Not yet recruiting NCT05901571 - Acupuncture and Escitalopram for Treating Major Depression Clinical Study N/A
Completed NCT02452892 - Low Field Magnetic Stimulation (LFMS) in Subjects With Treatment-Resistant Depression (TRD) N/A
Suspended NCT02546024 - Predictors of Treatment Response in Late-onset Major Depressive Disorder N/A
Completed NCT01407575 - Buprenorphine for Treatment Resistant Depression Phase 3
Completed NCT01583400 - Enhanced Collaborative Depression Treatment in Primary Care: The RESPECT-D-E Trial N/A
Completed NCT01152996 - Safety and Tolerability of Vortioxetine (LuAA21004) - Open Label Extension Study Phase 3
Enrolling by invitation NCT00762866 - Psychiatric Genotype/Phenotype Project Repository
Completed NCT00369343 - Study Evaluating Desvenlafaxine Succinate Sustained Release (DVS SR) Versus Placebo in Peri- and Postmenopausal Women Phase 3
Completed NCT00366652 - Study Evaluating the Effects of DVS SR and Duloxetine on the Pharmacokinetics of Desipramine in Healthy Subjects Phase 3
Completed NCT00384033 - Study Evaluating Desvenlafaxine Succinate Sustained Release (DVS SR) In The Treatment Of Major Depressive Disorder Phase 3
Completed NCT00316160 - Sexual Functioning Study With Antidepressants Phase 4
Completed NCT00149643 - Effectiveness of Fluoxetine in Young People for the Treatment of Major Depression and Marijuana Dependence Phase 2

External Links