Seasonal Affective Depression (SAD) Study

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00069459

Enrollment

250

Registered

2003-09-26

Start date

2003-09-23

Completion date

2004-06-03

Last updated

2017-09-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Depressive Disorder

Keywords

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

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

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

Interventions

DRUGExtended-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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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.

Design outcomes

Primary

Measure	Time frame
End of season depression-free rate.	7 months

Secondary

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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026