Depression: The Search for Treatment-Relevant Phenotypes-Pilot Study

This study has been completed.
Sponsor:
Collaborator:
Mental Health Intervention Research Center (MHIRC)
Information provided by:
University of Pittsburgh
ClinicalTrials.gov Identifier:
NCT00222820
First received: September 13, 2005
Last updated: September 19, 2005
Last verified: September 2005
  Purpose

We are doing this pilot study to learn more about four aspects of treating depression:

  1. The features of a depressed person’s mood and anxiety and how these features affect a person’s capacity to get better and stay better.
  2. If depressed people with certain features of mood and anxiety respond better to therapy, medication or a combination of therapy and medication.
  3. Whether or not a person’s personality traits affect how they respond to treatment.
  4. The gene involved in processing antidepressant medication

Condition Intervention Phase
Major Depression
Drug: escitalopram
Behavioral: Interpersonal Psychotherapy
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Depression: The Search for Treatment-Relevant Phenotypes

Further study details as provided by University of Pittsburgh:

Primary Outcome Measures:
  • Hamilton Rating Scale for Depression

Secondary Outcome Measures:
  • Inventory of Depressive Symptoms

Estimated Enrollment: 35
Study Start Date: April 2002
Estimated Study Completion Date: September 2004
Detailed Description:

This pilot study is an experimental investigation designed so that consenting subjects are randomly assigned to pharmacotherapeutic or psychotherapeutic interventions for depression.

For the initial phase of treatment, subjects will be randomly assigned to treatment with an SSRI, (escitalopram oxalate or citalopram hydrobromide), or with interpersonal psychotherapy (IPT). Escitalopram will be prescribed for all patients randomized to the medication arm of the study, unless the study psychiatrist determines that citalopram is more clinically appropriate. Escitalopram and citalopram are FDA-Approved SSRI antidepressants indicated for the treatment of depression. In order to optimize outcomes and emulate usual clinical practice, subjects who do not meet response criteria (defined as a 50% reduction in baseline Hamilton Rating Scale for Depression [HRS-D]) or meet stabilization criteria (defined as a mean HRS-D < 7 for 3 weeks) at acute phase Visit 7 or Visit 13 of treatment will have the other treatment added. Subjects who meet stabilization criteria (mean HRS-D < 7 for 3 weeks) at any time between acute phase Visit 13 and 21 will enter the 6-month continuation phase and continue with the treatment that led to their stabilization. Subjects who have not met stabilization criteria by acute phase Visit 21 will remain in active treatment and be offered alternative pharmacotherapy. Subjects who have not responded by acute phase Visit 32 will be discontinued from the protocol and referred for alternative treatment and care.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

1. Men and women 2 Age 18-65 3. Currently experiencing an episode of major depression 4. Not currently receiving effective treatment 5. Females of childbearing potential: practicing an acceptable form of birth control 6. Subjects with suicidal ideation are eligible as long as outpatient treatment is deemed safe 7. Willingness and ability to give informed consent.

Exclusion Criteria:

  1. History of manic or hypomanic episodes;
  2. History of schizophrenia or schizoaffective disorder;
  3. Current primary diagnosis of anorexia nervosa or bulimia nervosa;
  4. Current psychosis;
  5. Drug and/or alcohol dependence or abuse within the past three months (episodic abuse related to mood episodes will not exclude a subject);
  6. Antisocial personality disorder (other Axis II disorders will not be exclusionary);
  7. Organic affective syndrome;
  8. Renal or liver disease;
  9. Epilepsy;
  10. Cardiovascular disease;
  11. Uncontrolled illnesses, including untreated hypertension or unstable endocrine diseases.
  12. Women who are or are plan to become pregnant during the course of this study
  13. Subjects who require inpatient treatment because of suicidal risk or psychosis
  14. Subjects with a well-documented history of an inability to tolerate one of the study treatments or are currently receiving treatment with an effective antidepressant therapy
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00222820

Locations
United States, Pennsylvania
Western Psychaitric Institute and Clinic
Pittsburgh, Pennsylvania, United States, 15213
Sponsors and Collaborators
University of Pittsburgh
Mental Health Intervention Research Center (MHIRC)
Investigators
Principal Investigator: Ellen Frank, Ph.D. University of Pittsburgh
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00222820     History of Changes
Other Study ID Numbers: 011015
Study First Received: September 13, 2005
Last Updated: September 19, 2005
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Depression
Depressive Disorder
Depressive Disorder, Major
Behavioral Symptoms
Mood Disorders
Mental Disorders

ClinicalTrials.gov processed this record on October 19, 2014