OCD
Conditions
Keywords
OCD, SSRI, escitalopram, relapse
Brief summary
This study will determine the safety and effectiveness of escitalopram (Lexapro)in treating obsessive-compulsive disorder (OCD) symptoms.
Detailed description
OCD is a chronic and disabling disorder for which Selective Serotonin Reuptake Inhibitor(SSRI) drugs can be effective. The purpose of this study is to evaluate the effects of an SSRI, escitalopram, in OCD patients. This study will last 16 weeks and will comprise 2 phases. Phase 1 is an open label in which all participants will receive daily escitalopram for 8 weeks. Those who have responded to treatment at the end of the 8 weeks will be randomly assigned to either continue or discontinue their treatment for an additional 8 weeks. Those who do not respond to treatment at the end of Phase 1 will discontinue the study and be offered three free visits with a study clinician or referred elsewhere for treatment, based on the their preference. Study visits are made at baseline, and at Weeks 1, 2, 4, and 8 in Phase 1 and Weeks 12 and 16 in Phase 2.
Interventions
DRUGescitalopram
Open label Treatment: Escitalopram 10 mg/day for 1 week and then 20 mg /day for 7 weeks. Double Blind Treatment: Escitalopram 20 mg/day.
Placebo Comparator in double.blind phase.
Sponsors
Forest Laboratories
Duke University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Diagnosis of OCD * A minimum score of 16 on the Yale Brown Obsessive-Compulsive Scale (YBOCS) at both the screening and baseline visits
Exclusion criteria
* Lifetime history of psychosis or cognitive dysfunction due to a general medical condition or substance use * A primary diagnosis of another Axis I psychiatric disorder * Alcohol or other substance abuse or dependence within the last 6 months * Unstable medical condition * Clinically significant laboratory abnormality * Failure of a previous 10-week trial of citalopram of at least 40 mg/day or escitalopram 20 mg/day * Active suicidality * History of violent behavior in the past year or current risk of serious violence * A history of sensitivity to citalopram or escitalopram * Use of other investigational drugs within 30 days of baseline or other psychotropic drugs or herbs within 14 days of baseline (28 days for fluoxetine) * Need for concurrent psychotherapeutic intervention * Pregnant or lactating females.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Yale Brown Obsessive Compulsive Scale | Open Label Phase Baseline,Randomization Phase Baseline or Beginning | The Yale Brown Obsessive Compulsive Scale (YBOCS) is a clinician administered measure of the severity of obsessive compulsive disorder(OCD). Higher scores indicate a greater severity of OCD symptoms. The score can range from a minimum of zero to a maximum of forty. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Open Label Escitalopram Fourteen patients who met criteria for the study were enrolled in the open-label phase. Thirteen of these patients completed the open-label phase, while one patient was terminated early due to side effects. | 14 |
| Total | 14 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Open Label Escitalopram | Lack of Efficacy | 1 | 0 | 0 |
| Randomization Period | Lost to Follow-up | 0 | 1 | 0 |
| Randomization Period | Withdrawal by Subject | 0 | 1 | 0 |
Baseline characteristics
| Characteristic | Open Label Escitalopram |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 14 Participants |
| Age, Continuous | 39.14 years STANDARD_DEVIATION 13.27 |
| Region of Enrollment United States | 14 participants |
| Sex: Female, Male Female | 9 Participants |
| Sex: Female, Male Male | 5 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 14 | 0 / 7 | 0 / 5 |
| serious Total, serious adverse events | 0 / 14 | 0 / 7 | 0 / 5 |
Outcome results
Primary
Yale Brown Obsessive Compulsive Scale
The Yale Brown Obsessive Compulsive Scale (YBOCS) is a clinician administered measure of the severity of obsessive compulsive disorder(OCD). Higher scores indicate a greater severity of OCD symptoms. The score can range from a minimum of zero to a maximum of forty.
Time frame: Open Label Phase Baseline,Randomization Phase Baseline or Beginning
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Open Label Escitalopram | Yale Brown Obsessive Compulsive Scale | Beginning of Study Phase | 24.79 units on a scale | Standard Deviation 4.48 |
| Open Label Escitalopram | Yale Brown Obsessive Compulsive Scale | End of Study Phase | 15.36 units on a scale | Standard Deviation 7 |
| Randomization Placebo | Yale Brown Obsessive Compulsive Scale | Beginning of Study Phase | 12.71 units on a scale | Standard Deviation 6.13 |
| Randomization Placebo | Yale Brown Obsessive Compulsive Scale | End of Study Phase | 20.17 units on a scale | Standard Deviation 11.57 |
| Randomization Escitalopram | Yale Brown Obsessive Compulsive Scale | Beginning of Study Phase | 16.00 units on a scale | Standard Deviation 6.96 |
| Randomization Escitalopram | Yale Brown Obsessive Compulsive Scale | End of Study Phase | 15.8 units on a scale | Standard Deviation 7.79 |
Comparison: A Wilcoxon Signed Rank test was performed on the difference between the open label endpoint and baseline YBOCS scores.p-value: 0.0002Wilcoxon (Mann-Whitney)
Comparison: A Wilcoxon Rank Sum Test was performed on the difference in the pre and post randomization YBOCS scores, using grouping to either escitalopram or placebo as a grouping variable.p-value: 0.0417Wilcoxon Rank Sum Test