Seasonal Affective Depression (SAD) Study

Sponsor

GlaxoSmithKline (Industry)

Overall Status

Completed

CT.gov ID

NCT00069459

Collaborator

(none)

250

Enrollment

Locations

Arm

8.3

Actual Duration (Months)

5.2

Patients Per Site

0.6

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

A placebo controlled study evaluating the effectiveness of medication in preventing winter depressive episodes in patients with a history of Seasonal Affective Disorder

Condition or Disease	Intervention/Treatment	Phase
Depressive Disorder	Drug: Extended-release Bupropion Hydrochloride	Phase 1

Detailed Description

A 7-Month Multicenter, Parallel, Double-Blind, Placebo-Controlled Comparison of 150-300mg/day of Extended-release Bupropion Hydrochloride and Placebo for the Prevention of Seasonal Depressive Episodes in Subjects with a History of Seasonal Affective Disorder Followed by an 8-week Observational Follow-up Phase

Study Design

Study Type:

Interventional

Actual Enrollment :

250 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Treatment

Official Title:

A 7 Month, Multicenter, Parallel, Double-Blind, Placebo-Controlled Comparison of 150-300 mg/Day of Extended-Release Bupropion Hydrochloride and Placebo for the Prevention of Seasonal Depressive Episodes in Subjects With a History of Seasonal Affective Disorder Followed by an 8-week Observational Follow-up Phase

Actual Study Start Date :

Sep 23, 2003

Actual Primary Completion Date :

Jun 3, 2004

Actual Study Completion Date :

Jun 3, 2004

Arms and Interventions

Arm	Intervention/Treatment
Other: Extended-release Bupropion Hydrochloride Extended-release Bupropion Hydrochloride	Drug: Extended-release Bupropion Hydrochloride Bupropion hydrochloride will be available in dose strength of 150 and 300 milligram (mg). Subjects will receive one tablet of 150 mg bupropion hydrochloride from Day 1 to 7, from Day 8 to Week 27 will receive one tablet of 300 mg bupropion hydrochloride and from Week 28-29 one tablet of bupropion hydrochloride

Arm

Intervention/Treatment

Other: Extended-release Bupropion Hydrochloride

Extended-release Bupropion Hydrochloride

Drug: Extended-release Bupropion Hydrochloride

Bupropion hydrochloride will be available in dose strength of 150 and 300 milligram (mg). Subjects will receive one tablet of 150 mg bupropion hydrochloride from Day 1 to 7, from Day 8 to Week 27 will receive one tablet of 300 mg bupropion hydrochloride and from Week 28-29 one tablet of bupropion hydrochloride

Outcome Measures

Primary Outcome Measures

End of season depression-free rate. [7 months]

Secondary Outcome Measures

Time to onset of a seasonal depressive episode.Change from randomization on SIGH-SAD and HAMD-17. [7 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

History of Major Depressive Disorder (MDD) with a seasonal pattern.

Exclusion Criteria:

Current or past history of seizure disorder or brain injury.
History or current diagnosis of anorexia nervosa or bulimia.
Recurrent summer depression more frequently than winter depression.
Primary diagnosis of panic disorder, Obsessive Compulsive Disorder (OCD), Post-traumatic Stress Disorder(PTSD), acute distress disorder, bipolar II disorder or other psychotic disorders.
Initiated psychotherapy within the last 3 months.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	GSK Investigational Site	Anchorage	Alaska	United States	99508
2	GSK Investigational Site	Hamden	Connecticut	United States	06518
3	GSK Investigational Site	Newark	Delaware	United States	19713
4	GSK Investigational Site	Wilmington	Delaware	United States	19808
5	GSK Investigational Site	Washington, D.C.	District of Columbia	United States	20016
6	GSK Investigational Site	Boise	Idaho	United States	83702
7	GSK Investigational Site	Edwardsville	Illinois	United States	62025
8	GSK Investigational Site	Hoffman Estates	Illinois	United States	60194
9	GSK Investigational Site	Northfield	Illinois	United States	60093
10	GSK Investigational Site	Oak Brook	Illinois	United States	60523
11	GSK Investigational Site	Oakbrook Terrace	Illinois	United States	60181
12	GSK Investigational Site	Cedar Rapids	Iowa	United States	52401
13	GSK Investigational Site	Overland Park	Kansas	United States	66211
14	GSK Investigational Site	Baltimore	Maryland	United States	21204
15	GSK Investigational Site	Rockville	Maryland	United States	20852
16	GSK Investigational Site	Belmont	Massachusetts	United States	02478
17	GSK Investigational Site	Farmington Hills	Michigan	United States	48334
18	GSK Investigational Site	Minneapolis	Minnesota	United States	55454
19	GSK Investigational Site	Saint Louis	Missouri	United States	63108
20	GSK Investigational Site	Omaha	Nebraska	United States	68198
21	GSK Investigational Site	Kenilworth	New Jersey	United States	07033
22	GSK Investigational Site	Moorestown	New Jersey	United States	08057
23	GSK Investigational Site	Piscataway	New Jersey	United States	08854
24	GSK Investigational Site	Princeton	New Jersey	United States	08540
25	GSK Investigational Site	Albany	New York	United States	12208
26	GSK Investigational Site	Lawrence	New York	United States	11559
27	GSK Investigational Site	New York	New York	United States	10021
28	GSK Investigational Site	New York	New York	United States	10032
29	GSK Investigational Site	New York	New York	United States	10128
30	GSK Investigational Site	Rochester	New York	United States	14618
31	GSK Investigational Site	Cincinnati	Ohio	United States	45219
32	GSK Investigational Site	Columbus	Ohio	United States	43210
33	GSK Investigational Site	Lyndhurst	Ohio	United States	44124
34	GSK Investigational Site	Toledo	Ohio	United States	43623
35	GSK Investigational Site	Eugene	Oregon	United States	97401
36	GSK Investigational Site	Portland	Oregon	United States	97201
37	GSK Investigational Site	Portland	Oregon	United States	97209
38	GSK Investigational Site	Portland	Oregon	United States	97210
39	GSK Investigational Site	Allentown	Pennsylvania	United States	18104
40	GSK Investigational Site	Havertown	Pennsylvania	United States	19083
41	GSK Investigational Site	Philadelphia	Pennsylvania	United States	19106
42	GSK Investigational Site	Lincoln	Rhode Island	United States	02865-4208
43	GSK Investigational Site	Woodstock	Vermont	United States	05091
44	GSK Investigational Site	Spokane	Washington	United States	99204
45	GSK Investigational Site	Brown Deer	Wisconsin	United States	53223
46	GSK Investigational Site	Madison	Wisconsin	United States	53719
47	GSK Investigational Site	Menomonee Falls	Wisconsin	United States	53051
48	GSK Investigational Site	Middleton	Wisconsin	United States	53562-2215

Sponsors and Collaborators

GlaxoSmithKline

Investigators

Study Director: GSK Clinical Trials, GlaxoSmithKline

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

GlaxoSmithKline

ClinicalTrials.gov Identifier:

NCT00069459

Other Study ID Numbers:

100006

First Posted:

Sep 26, 2003

Last Update Posted:

Sep 25, 2017

Last Verified:

Sep 1, 2017

Keywords provided by GlaxoSmithKline

Winter depression, winter blues, depression, seasonal depression, seasonal affective disorder

Additional relevant MeSH terms:

Depressive Disorder

Seasonal Affective Disorder

Bupropion

Study Results

No Results Posted as of Sep 25, 2017