Trial Outcomes & Findings for Effect of D-cycloserine Plus Cognitive Behavioral Therapy on People With Social Phobia (NCT NCT00515879)

Results Overview

Social Phobic Disorders Severity and Change Form (SPD-SC Form; Liebowitz et al., 1992) is an expansion and adaptation of the Clinical Global Impression Scale (CGI) by Guy (1976) to SAD. Similar to the original CGI scale, the SPD-SC Form is rated by an independent evaluator on a 7-point scale to indicate severity (1=normal/not ill; 2 = minimally ill; 3=mildly ill; 4=moderately ill; 5=markedly ill; 6=severely ill; 7=among the most severely ill) and improvement (1=very much improved; 2=much improved; . 3=minimally improved' 4 = no change; 5=nimimal deterioration; 6=severe deterioration; 7=very severe deterioration). The primary outcome measure is units of a scale ranging from 1 (very much improved) to 7 (very severe deterioration).

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

169 participants

Primary outcome timeframe

Measured at Months 3 (immediately after treatment)

Results posted on

2019-02-26

Participant Flow

Prospective participants were recruited between September 2007 and June 2011 through referrals to the three study sites (Boston University \[BU\], Massachusetts General Hospital \[MGH\], and Southern Methodist University \[SMU\]), from other area clinical facilities and programs, and from advertisements.

Study participants underwent a two-step screening evaluation, consisting of 1) telephone screening, and 2) psychiatric assessment and medical history taking with physical examination.

Participant milestones

Participant milestones
Measure	D-cycloserine-augmented CBT Participants will receive D-cycloserine augmented cognitive behavioral therapy	Placebo-augmented CBT Participants will receive placebo augmented cognitive behavioral therapy
Overall Study STARTED	87	82
Overall Study COMPLETED	62	62
Overall Study NOT COMPLETED	25	20

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Effect of D-cycloserine Plus Cognitive Behavioral Therapy on People With Social Phobia

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	D-cycloserine-augmented CBT n=87 Participants Participants will receive D-cycloserine augmented cognitive behavioral therapy	Placebo-augmented CBT n=82 Participants Participants will receive placebo augmented cognitive behavioral therapy	Total n=169 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	87 Participants n=5 Participants	82 Participants n=7 Participants	169 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Continuous	34.6 years STANDARD_DEVIATION 7.89 • n=5 Participants	30.5 years STANDARD_DEVIATION 8.9 • n=7 Participants	32.55 years STANDARD_DEVIATION 8.41 • n=5 Participants
Sex: Female, Male Female	44 Participants n=5 Participants	30 Participants n=7 Participants	74 Participants n=5 Participants
Sex: Female, Male Male	43 Participants n=5 Participants	52 Participants n=7 Participants	95 Participants n=5 Participants
Region of Enrollment United States	87 participants n=5 Participants	82 participants n=7 Participants	169 participants n=5 Participants

PRIMARY outcome

Timeframe: Measured at Months 3 (immediately after treatment)

Social Phobic Disorders Severity and Change Form (SPD-SC Form; Liebowitz et al., 1992) is an expansion and adaptation of the Clinical Global Impression Scale (CGI) by Guy (1976) to SAD. Similar to the original CGI scale, the SPD-SC Form is rated by an independent evaluator on a 7-point scale to indicate severity (1=normal/not ill; 2 = minimally ill; 3=mildly ill; 4=moderately ill; 5=markedly ill; 6=severely ill; 7=among the most severely ill) and improvement (1=very much improved; 2=much improved; . 3=minimally improved' 4 = no change; 5=nimimal deterioration; 6=severe deterioration; 7=very severe deterioration). The primary outcome measure is units of a scale ranging from 1 (very much improved) to 7 (very severe deterioration).

Outcome measures

Outcome measures
Measure	D-cycloserine-augmented CBT n=87 Participants Participants will receive D-cycloserine augmented cognitive behavioral therapy	Placebo-augmented CBT n=82 Participants Participants will receive placebo augmented cognitive behavioral therapy
Social Phobic Disorders Severity and Change Form	2.68 Units on a scale Interval 2.38 to 2.98	2.95 Units on a scale Interval 2.64 to 3.27

PRIMARY outcome

Timeframe: Measured at Months 3

The Liebowitz Social Anxiety Scale (LSAS; Liebowitz, 1987) is a 24-item scale that provides separate scores for fear and avoidance in social and performance situations; it is widely used in treatment studies of SAD. Total scores range from 0 (no anxiety) to 144 (maximum).

Outcome measures

Outcome measures
Measure	D-cycloserine-augmented CBT n=87 Participants Participants will receive D-cycloserine augmented cognitive behavioral therapy	Placebo-augmented CBT n=82 Participants Participants will receive placebo augmented cognitive behavioral therapy
Liebowitz Social Anxiety Scale (LSAS)	39.19 LSAS scores Interval 34.79 to 43.59	42.44 LSAS scores Interval 37.94 to 47.03

SECONDARY outcome

Timeframe: Measured at Months 3, 6, and 9 post-treatment

Population: The number of analyzed participants differs from the overall number analyzed due to participant dropout between treatment and subsequent follow up time points.

The Social Phobia and Anxiety Inventory (SPAI; Turner, Beidel, Dancu, and Stanley, 1989) is a 45-item self-report measure on the frequency (0 = Never, 1 = Very Infrequent, 2 = Infrequent, 3 = Sometimes, 4 = Frequent, 5 = Very Frequent, 6 = Always) of one's experiences. The inventory includes 32 items assessing somatic, cognitive, and behavioral symptoms of social anxiety and 13 items assessing agoraphobia. The final score is calculated by subtracting the agoraphobia subscale total (max = 78; min = 0) from the social phobia subscale total (max = 192; min = 0). Thus, the final total scores range from 0-114, where higher final scores indicate higher social anxiety.

Outcome measures

Outcome measures
Measure	D-cycloserine-augmented CBT n=87 Participants Participants will receive D-cycloserine augmented cognitive behavioral therapy	Placebo-augmented CBT n=82 Participants Participants will receive placebo augmented cognitive behavioral therapy
Social Phobia and Anxiety Inventory 3 Months	71.08 score on a scale Standard Deviation 28.585	73.74 score on a scale Standard Deviation 30.311
Social Phobia and Anxiety Inventory 6 Months	69.64 score on a scale Standard Deviation 32.188	71.97 score on a scale Standard Deviation 30.566
Social Phobia and Anxiety Inventory 9 Months	67.67 score on a scale Standard Deviation 31.847	67.74 score on a scale Standard Deviation 33.289

SECONDARY outcome

Timeframe: Measured at Months 3, 6, and 9 post-treatment

Population: The number of analyzed participants differs from the overall number analyzed due to participant dropout between treatment and subsequent follow up time points.

The Quality of Life Enjoyment and Satisfaction Questionnaire (Endicott et al., 1993) is a 16-item self-report measure that rates aspects of quality of life, including physical health, mood, activities of daily living, and overall life satisfaction. Responses are scored on a 5 point scale. The maximum score is 70 (high satisfaction) and the minimum is 14 (low satisfaction); scores are generally expressed as a percentage of maximum total score (0-100).

Outcome measures

Outcome measures
Measure	D-cycloserine-augmented CBT n=87 Participants Participants will receive D-cycloserine augmented cognitive behavioral therapy	Placebo-augmented CBT n=82 Participants Participants will receive placebo augmented cognitive behavioral therapy
Quality of Life Enjoyment and Satisfaction Questionnaire 6 Months	66.32 percentage of maximum Standard Deviation 16.066	67.44 percentage of maximum Standard Deviation 14.872
Quality of Life Enjoyment and Satisfaction Questionnaire 3 Months	67.77 percentage of maximum Standard Deviation 14.075	67.44 percentage of maximum Standard Deviation 14.00
Quality of Life Enjoyment and Satisfaction Questionnaire 9 Months	67.08 percentage of maximum Standard Deviation 16.063	69.58 percentage of maximum Standard Deviation 11.761

SECONDARY outcome

Timeframe: Measured at Months 3, 6, and 9 post-treatment

Population: The number of analyzed participants differs from the overall number analyzed due to participant dropout between treatment and subsequent follow up time points.

Liebowitz Self-Rated Disability Scale (Schneier et al., 1994) is an 11-item scale assessing impairment specific to social anxiety. Current (past 2 weeks) and most severe lifetime impairment due to social anxiety disorder are rated on a 0-3 scale of degree of limitation (0=problem does not limit me at all; 3=problem limits me severely). The maximum score is 44 (severe impairment) and the minimum is 0 (no impairment).

Outcome measures

Outcome measures
Measure	D-cycloserine-augmented CBT n=87 Participants Participants will receive D-cycloserine augmented cognitive behavioral therapy	Placebo-augmented CBT n=82 Participants Participants will receive placebo augmented cognitive behavioral therapy
Liebowitz Self-Rated Disability Scale 3 Months	15.6117 score on a scale Standard Deviation 7.25681	14.0303 score on a scale Standard Deviation 7.79688
Liebowitz Self-Rated Disability Scale 6 Months	15.5283 score on a scale Standard Deviation 7.03686	14.4977 score on a scale Standard Deviation 7.98470
Liebowitz Self-Rated Disability Scale 9 Months	15.3269 score on a scale Standard Deviation 7.72461	14.3130 score on a scale Standard Deviation 7.62630

SECONDARY outcome

Timeframe: Measured at Months 3, 6, and 9 post-treatment

Population: The number of analyzed participants differs from the overall number analyzed due to participant dropout between treatment and subsequent follow up time points.

The Range of Impaired Functioning Tool (LIFE-RIFT, Leon et al., 2000) is a clinician rated scale assessing functioning in four domains: work, interpersonal relationships, recreation, and global satisfaction. Each domain is scored 0-5 (0=not applicable, 1=no impairment, 2=slight impairment, 3=mild impairment, 4=moderate impairment, 5=severe impairment). The total score is the sum of each domain's score, with a maximum score of 20 (severe impairment) and a minimum score of 4 (no impairment).

Outcome measures

Outcome measures
Measure	D-cycloserine-augmented CBT n=87 Participants Participants will receive D-cycloserine augmented cognitive behavioral therapy	Placebo-augmented CBT n=82 Participants Participants will receive placebo augmented cognitive behavioral therapy
Range of Impaired Functioning Tool 3 Months	8.5256 score on a scale Standard Deviation 2.780	8.6667 score on a scale Standard Deviation 2.80841
Range of Impaired Functioning Tool 6 Months	8.6143 score on a scale Standard Deviation 2.67730	8.5430 score on a scale Standard Deviation 2.82987
Range of Impaired Functioning Tool 9 Months	8.6232 score on a scale Standard Deviation 2.80284	7.7458 score on a scale Standard Deviation 2.43957

Adverse Events

D-cycloserine-augmented CBT

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Placebo-augmented CBT

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Stefan G. Hofmann, Ph.D., Professor of Psychology

Boston University

Phone: 617 353 9233

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place