Mild Depression 2 Week Observational Study

• ClinicalTrials.gov Identifier: NCT00285831
• Recruitment Status: Completed
• First Posted: February 2, 2006
• Last Update Posted: September 9, 2019
• Sponsor: Stanford University
• Collaborators: GlaxoSmithKline; Long Island Jewish Medical Center; Rush University Medical Center
• Information provided by: Stanford University

Study Description

Brief Summary:

The purpose of this study is to assess whether the dysphoric-like depressive characteristics observed in people with epilepsy are unique to this patient population in comparison to three control groups: Mild Depression (enrolled at Stanford University), Migraine Headaches (enrolled at Long Island Jewish Medical Center), and Multiple Sclerosis (enrolled at Rush University Medical Center).

Condition or disease
Depressive Disorder

Detailed Description:

This is a multicenter study consisting of a Screen and Retest phase conducted in two separate days separated by a two-week period. After providing written informed consent and meeting protocol-defined inclusion criteria at Screen, patients will be administered the Wide Range Achievement Test 3 (WRAT3) to ensure adequate word reading ability with which to complete the self-report forms. Patients who achieve a satisfactory score will be interviewed using the Mini International Neuropsychiatric Interview (MINI). Afterwards, each patient will first complete the 46 item Mood and Anxiety Symptom List in Epilepsy (MAS-E) and then five additional questionnaires in random order. Patients will also be given the opportunity to be rated by a proxy (e.g., caregiver, family member, friend) who will also complete the MAS-E.

Patients will return the completed documents to the investigator and be given an additional MAS-E to take home. In the Retest phase, patients will be asked to complete the MAS-E again exactly 14 days from the date of the Screen visit. The proxy will also be given an additional MAS-E and be asked to complete the MAS-E exactly 14 days from completion of the first MAS-E. The documents shall be returned to the clinic via U.S. mail on the same day of completion. It is not necessary to have a proxy to participate in this study.

Total study participation takes 2 weeks and approximately one visit to the clinic for the screening visit.

Study Design

• Study Type: Observational
• Actual Enrollment: 36 participants
• Time Perspective: Prospective
• Official Title: Dysphoric-like Disorder of Epilepsy, Is it Unique?
• Actual Study Start Date: December 2005
• Actual Primary Completion Date: March 2009
• Actual Study Completion Date: March 2009

Groups and Cohorts

Outcome Measures

Eligibility Criteria

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

Criteria

Inclusion Criteria::

" Male or female 18 years of age or older. " Presence of a Depressive disorder that presents as a dysthymic or minor depressive disorder and whose score on the Beck Depression Inventory (BDI) range between 11 and 20. Patients with major depression will be excluded.

" Is currently on stable doses of medications i.e., no change in treatment in the previous 30 days.

" Achieves a satisfactory score on the WRAT3 (standard score is > 69). " Is capable of completing the self-reporting questionnaires. " Is willing and able to provide written informed consent and comply with the study protocol
 Exclusion Criteria:" Presence of a clinically significant comorbidity of an unstable or progressive nature (e.g., psychosis, delirium) that could, in the opinion of the investigator, prevent completion of the questionnaires or warrant immediate medical intervention.

" Participation in an investigational trial within the past 30 days. " Inability to communicate well with site study personnel, e.g. inability to read or understand English, poor mental development or impaired brain function.

" Patients with a clinical picture that meets criterion of major depression.

Contacts and Locations

Locations

United States, California

Stanford University School of Medicine

Stanford, California, United States, 94305

Sponsors and Collaborators

Stanford University

GlaxoSmithKline

Long Island Jewish Medical Center

Rush University Medical Center

Investigators

• Principal Investigator: John J Barry; Stanford University

More Information

• ClinicalTrials.gov Identifier: NCT00285831
• Other Study ID Numbers: 95879
• First Posted: February 2, 2006
• Last Update Posted: September 9, 2019
• Last Verified: September 2019

Additional relevant MeSH terms:

Depressive Disorder; Mood Disorders; Mental Disorders