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| ID | Type | Description | Link |
|---|---|---|---|
| 1R01MH093402-01A1 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Mental Health (NIMH) | NIH |
| University of South Florida | OTHER |
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The purpose of this study is to find out if D-Cycloserine (DCS), taken at the same time as a child gets cognitive behavioral therapy (CBT) can help children with pediatric obsessive-compulsive disorder.
Cognitive Behavior Therapy is a talking therapy that will teach children new skills to better cope with his/her OCD. CBT usually uses "exposure-based therapy". This means that the person with OCD slowly learns to deal with things they usually avoid. This is done by moving from less stressful situations to more challenging ones.
The investigators hope to enroll about 75 children ages 7-17 years old with OCD in this study at Massachusetts General Hospital (MGH). The National Institute of Mental Health (NIMH) is paying for this study to be done.
If your child qualifies for the study, the investigators will assign him or her by chance (like a coin toss) to either the DCS group or the placebo group. You and the study doctor cannot choose your child's study group. Your child will have an equal chance (1 in 2) of being assigned to the DCS group.
Your child will be asked to take one or two capsules of the study drug (either DCS or placebo, depending which study group they were assigned to) one hour before CBT visits 4-10. The study coordinator will give your child the study drug at the location of the CBT sessions. This is to make sure that your child takes the study drug one hour before his/her scheduled therapy session. We will ask you to record any bad side effect from the study drug that your child may have before each CBT session.
It will take your child about 34 weeks to complete the study. During this time, the investigators will ask you and your child to make a minimum of 17 trips to the study center. There may be up to 23 trips when including CBT Booster sessions.
This study uses a placebo. The placebo looks exactly like the DCS, but it contains no DCS. The investigators use placebos in research studies to learn if the the results are caused by the study drug or are due to other reasons. This is a double-blind study. A double-blind study is a study where both the doctor and the study participant do not know whether the study participant is being given DCS or placebo.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| D-Cycloserine | Active Comparator |
| |
| Sugar Pill | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| D-Cycloserine | Drug | 25mg dose for children weighing between 22.5kg and 45kg (dose = approx. .7mg/kg) 50mg dose for children weighing greater than 46kg (dose = approx. .7mg/kg) Dose given 7 times, every seven days, except for the third dose, which will be given three days after the second dose. All doses given 1 hour prior to therapy session. |
| Measure | Description | Time Frame |
|---|---|---|
| Children's Yale-Brown Obsessive Compulsive Scale (CY-BOCS) | The CY-BOCS is a measure of severity of OCD symptoms, including interference, time spent on thoughts or behaviors, distress, resistance, etc. The CY-BOCS is measured from 0 to 40, with larger values indicating more severe symptoms. Our outcome measure was the difference between the post treatment and randomization scores. When those values are negative, it indicates a reduction in symptom severity. | Change from Score at Randomization to Post Treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical Global Impression-Severity (CGI-Severity) | The Clinical Global Impression-Severity is a 7-point clinician rating of illness severity, with a score of 0 indicating no illness and a score of 6 indicating extremely severe symptoms. Because the secondary outcome was the change in score from randomization to post treatment, a more negative score indicates a greater reduction in symptom severity. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Daniel A Geller, M.D. | Massachusetts General Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20817153 | Background | Storch EA, Murphy TK, Goodman WK, Geffken GR, Lewin AB, Henin A, Micco JA, Sprich S, Wilhelm S, Bengtson M, Geller DA. A preliminary study of D-cycloserine augmentation of cognitive-behavioral therapy in pediatric obsessive-compulsive disorder. Biol Psychiatry. 2010 Dec 1;68(11):1073-6. doi: 10.1016/j.biopsych.2010.07.015. |
| Label | URL |
|---|---|
| The OCD and Related Disorder Program at Massachusetts General Hospital | View source |
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206 subjects were initially enrolled at MGH and USF. Of those, 32 were considered screen fails and 32 were not randomized either because they did not meet inclusion or exclusion criteria at randomization or because they withdrew consent or dropped out. Thus, 142 participants were randomized.
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| ID | Title | Description |
|---|---|---|
| FG000 | D-Cycloserine | D-Cycloserine: 25mg dose for children weighing between 22.5kg and 45kg (dose = approx. .7mg/kg) 50mg dose for children weighing greater than 46kg (dose = approx. .7mg/kg) Dose given 7 times, every seven days, except for the third dose, which will be given three days after the second dose. All doses given 1 hour prior to therapy session. |
| FG001 | Sugar Pill | Placebo: Sugar pill |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
206 subjects were initially enrolled at MGH and USF. Of those, 32 were considered screen fails and 32 were not randomized either because they did not meet inclusion or exclusion criteria at randomization or because they withdrew consent or dropped out. Thus, 142 participants were randomized.
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| ID | Title | Description |
|---|---|---|
| BG000 | D-Cycloserine | D-Cycloserine: 25mg dose for children weighing between 22.5kg and 45kg (dose = approx. .7mg/kg) 50mg dose for children weighing greater than 46kg (dose = approx. .7mg/kg) Dose given 7 times, every seven days, except for the third dose, which will be given three days after the second dose. All doses given 1 hour prior to therapy session. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Children's Yale-Brown Obsessive Compulsive Scale (CY-BOCS) | The CY-BOCS is a measure of severity of OCD symptoms, including interference, time spent on thoughts or behaviors, distress, resistance, etc. The CY-BOCS is measured from 0 to 40, with larger values indicating more severe symptoms. Our outcome measure was the difference between the post treatment and randomization scores. When those values are negative, it indicates a reduction in symptom severity. | Posted | Mean | Standard Deviation | Change in score from randomization | Change from Score at Randomization to Post Treatment |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | D-Cycloserine | D-Cycloserine: 25mg dose for children weighing between 22.5kg and 45kg (dose = approx. .7mg/kg) 50mg dose for children weighing greater than 46kg (dose = approx. .7mg/kg) Dose given 7 times, every seven days, except for the third dose, which will be given three days after the second dose. All doses given 1 hour prior to therapy session. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Headache | Nervous system disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Daniel Geller | MGH | 617 724 5141 | dan.geller@mgh.harvard.edu |
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| ID | Term |
|---|---|
| D009771 | Obsessive-Compulsive Disorder |
| ID | Term |
|---|---|
| D001008 | Anxiety Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D003523 | Cycloserine |
| ID | Term |
|---|---|
| D007555 | Isoxazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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|
| Placebo | Drug | Sugar pill |
|
| Change from Randomization Point to Post Treatment |
| BG001 |
| Sugar Pill |
Placebo: Sugar pill |
| BG002 | Total | Total of all reporting groups |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| OG001 | Sugar Pill | Placebo: Sugar pill |
|
|
| Secondary | Clinical Global Impression-Severity (CGI-Severity) | The Clinical Global Impression-Severity is a 7-point clinician rating of illness severity, with a score of 0 indicating no illness and a score of 6 indicating extremely severe symptoms. Because the secondary outcome was the change in score from randomization to post treatment, a more negative score indicates a greater reduction in symptom severity. | Posted | Mean | Standard Deviation | Change in score from randomization | Change from Randomization Point to Post Treatment |
|
|
|
| 0 |
| 70 |
| 60 |
| 70 |
| EG001 | Sugar Pill | Placebo: Sugar pill | 0 | 72 | 70 | 72 |
| Constipation | Gastrointestinal disorders | Systematic Assessment |
|
| Poor Memory | Nervous system disorders | Systematic Assessment |
|
| Nausea or Vomiting | Gastrointestinal disorders | Systematic Assessment |
|
| Feeling Drowsy or Sleepy | General disorders | Systematic Assessment |
|
| Blurred Vision or Reading | Eye disorders | Systematic Assessment |
|
| Increased Appetite | Metabolism and nutrition disorders | Systematic Assessment |
|
| Difficulty Starting Urination | Renal and urinary disorders | Systematic Assessment |
|
| Trouble Concentrating | Nervous system disorders | Systematic Assessment |
|
| Nightmares | Nervous system disorders | Systematic Assessment |
|
| Difficulty Sitting Still | General disorders | Systematic Assessment |
|
| Heartbeat Irregular or Pounding | Cardiac disorders | Systematic Assessment |
|
| Diarrhea | Gastrointestinal disorders | Systematic Assessment |
|
| Frequent Need to Urinate | Renal and urinary disorders | Systematic Assessment |
|
| Dry Mouth | General disorders | Systematic Assessment |
|
| Decreased Appetite | Metabolism and nutrition disorders | Systematic Assessment |
|
| Tremors or Shakiness | General disorders | Systematic Assessment |
|
| Skin Rash or Irritation | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Ringing in the Ears | Ear and labyrinth disorders | Systematic Assessment |
|
| Sweating | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Faintness or Lightheadedness | Nervous system disorders | Systematic Assessment |
|
| Poor Coordination | General disorders | Systematic Assessment |
|
| Stiffness in the Muscles | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Trouble Falling Asleep | General disorders | Systematic Assessment |
|
| Feeling Tired | General disorders | Systematic Assessment |
|
| Waking up During the Night | General disorders | Systematic Assessment |
|
| Waking up too Early in the Morning | General disorders | Systematic Assessment |
|
| Feeling Confused | Nervous system disorders | Systematic Assessment |
|
| Feeling Nervous or Sad | Psychiatric disorders | Systematic Assessment |
|
| Upper respiratory tract infection | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Ear infection | Ear and labyrinth disorders | Systematic Assessment |
|
| Sore throat | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Coughing | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Stomach pain or discomfort | Gastrointestinal disorders | Systematic Assessment |
|
| Mouth or dental pain | General disorders | Systematic Assessment |
|
| Fever | General disorders | Systematic Assessment |
|
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Body abrasions and bruising | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Anxiety | Psychiatric disorders | Systematic Assessment |
|
| Seasonal Allergies | Immune system disorders | Systematic Assessment |
|
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| D023303 |
| Oxazolidinones |
| D010080 | Oxazoles |
| D012694 | Serine |
| D021542 | Amino Acids, Neutral |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |